By INAL

Philips—Holter Cardiology Monitoring Systems: Performance May Be AffectedDevice Term(s): Information Systems, Data Management, Cardiology [18-119];

Monitors, Personal [20-183];

Recorders, Electronic Storage, Data, Electrocardiography [18-360]Product Identifier: Holter Cardiology Monitoring Systems [Capital Equipment]

Model/Catalog Nos.: 1810, 2010+; Software Versions: 2.9, 2.9.1

 

Geographic Regions: (Impact in additional regions has not been identified or ruled out at the time of this posting), Canada

Manufacturer: Philips Healthcare North America [453551], 22100 Bothell-Everett Hwy PO Box 3003, Bothell, WA 98041-3003, United States

Problem: Health Canada states that the above systems may have performance problems.  Health Canada also states that the manufacturer initiated a recall on Mach 30, 2009.  The manufacturer has not confirmed the information provided in the source material.

Regulatory Agency:
Designation:
Health Canada
Type II Recall No. 47704

Action Needed: Verify that you have been contacted by Philips.  Identify any affected product in your inventory.

For Further Information:
Geographic Location:
Contact:
Web Site:
Worldwide
Philips local representative

Source:

  • Health Canada. Medical device recall listings [online]. 2009 Apr 27 [cited 2009 May 13]. Available from Internet: Click here.

 

Comment:

  • This alert is a living document and may be updated when ECRI Institute receives additional information.  In circumstances in which we determine that it is appropriate for customers to repeat their review of an issue (e.g., when additional affected product has been identified), we will post a separate update alert.  In other cases, we may add information, such as additional commentary, recommendations, and/or source documents, to the original alert.
  • This alert is based on information that may not be independently verified as to its accuracy, completeness, or causal relationship to the product or its supplier.
  • The manufacturer has not confirmed the geographic distribution of affected product.  ECRI Institute recommends that you check your inventory for this product regardless of where you are located.

 

Suggested Distribution: Cardiology/Cardiac Catheterization Laboratory, Clinical/Biomedical Engineering, Home Care

Verification History: Alert Confirmed by Non-U.S. Regulatory Agency[5/13/2009 2:05:16 PM]

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Ansell—DermaPrene Ultra Surgical Gloves: May Experience Premature Degradation; May Tear during UseDevice Term(s): Gloves, Surgical, Hypoallergenic [11-884]

Product Identifier: Expand identifier information Collapse identifier information DermaPrene Ultra Surgical Gloves [Consumable]

Sizes: Product Nos.: Shipping Lot Nos.:
6 8512 0810015305
6.5 8513 0810007705,  0810015405, 0812017905
7 8514 0810003305, 0810007305, 0810007805, 0810015505
7.5 8515 0810003405,  0810007905, 0810014405, 0810015805
8 8516 0810008005, 0810014505, 0810015605, 0811015605, 0811017805
8.5 8517 0810003605, 0810015705
9 8518 0811017405

637 cases manufactured between October 22 and 23, 2008

 

Geographic Regions: (Impact in additional regions has been identified as of [May 15, 2009]) Canada, Chile, Panama, Peru, U.S.

Distributor: Various Distributors

Manufacturer: Ansell Healthcare Products LLC [365784], 200 Schulz Dr, Red Bank, NJ 07701, United States

Problem: In a May 4, 2009, letter submitted by an ECRI Institute member hospital, Ansell states that recent data indicates that specific lots of the above gloves may have experienced premature degradation.  Use of the gloves could result in tearing during use.  The May 4, 2009, letter instructed Ansell distributors to contact customers regarding return of affected product.

Action Needed: Verify that you have been contacted by Ansell or your Ansell distributor.  Identify, isolate, and discontinue use of any affected product in your inventory.  Return affected product to your Ansell distributor.

For Further Information:
Geographic Location: Contacts: Web Site:
Worldwide Ansell distributor
Ansell local representative Click here

 

Source:

  • Letter submitted by ECRI Institute member hospital.
  • Manufacturer.

 

Comment:

  • This alert is a living document and may be updated when ECRI Institute receives additional information.  In circumstances in which we determine that it is appropriate for customers to repeat their review of an issue (e.g., when additional affected product has been identified), we will post a separate update alert.  In other cases, we may add information, such as additional commentary, recommendations, and/or source documents, to the original alert.

 

Suggested Distribution: CSR/Materials Management, Emergency/Outpatient Services, Infection Control, Nursing, OR/Surgery

Verification History: One Member Submission [5/13/2009 2:50:31 PM]; Alert Confirmed by Mfr./Dist. [5/15/2009 9:59:48 AM]; Fully verified [5/15/2009 9:59:53 AM]

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Cardinal Health—Ansell DermaPrene Ultra Surgical Gloves: May Experience Premature Degradation; May Tear during UseDevice Term(s): Gloves, Surgical, Hypoallergenic [11-884]

Product Identifier: Expand identifier information Collapse identifier information [May 14, 2009]  Derma Prene Ultra Surgical Gloves [Consumable]

Ansell Catalog Nos.: Cardinal Health Catalog Nos.: Lot Nos.:
8512 8512, 8512A 0810015305
8513 8513A, AD8513, XAD8513 0810007705, 0810015405, 0812017905
8514 8514A, XAD8514 0810003305, 0810007305, 0810007805, 0810015505
8515 8515A, AD8515, XAD8515 0810003405, 0810007905, 0810014405, 0810015805
8516 8516A, AD8516, XAD8516 0810008005, 0810014505, 0810015605, 0811015605, 0811017805
8517 8517, 8517A 0810003605, 0810015705
8518 8518, 8518A, X8518, X8518A 0811017405

 [May 14, 2009]  DermaPrene Ultra Surgical Gloves [Consumable] Catalog Nos.: 8512 through 8518 637 cases manufactured between October 22 and 23, 2008

 

Geographic Regions: (Impact in additional regions has not been identified or ruled out at the time of this posting), U.S.

Distributor: Cardinal Health Inc [304923], 1430 Waukegan Rd, McGaw Park, IL 60085, United States

Manufacturer: Ansell Healthcare Products LLC [365784], 200 Schulz Dr, Red Bank, NJ 07701, United States

See: Alert Accession No. A12254

Update Information:   [May 14, 2009]  In the above-referenced alert, ECRI Institute reported that Ansell initiated a recall of the above gloves because they may have experienced premature degradation, potentially resulting in tearing during use. In a May 12, 2009, Urgent Product Recall letter submitted by an ECRI Institute member hospital, Cardinal Health initiated a subrecall of the above gloves. The manufacturer and the distributor have not confirmed the information provided in the source material. To read the complete text from Alert Accession No. A12254, see below.  [May 14, 2009]  In a May 4, 2009, letter submitted by an ECRI Institute member hospital, Ansell states that recent data indicates that specific lots of the above gloves may have experienced premature degradation.  Use of the gloves could result in tearing during use.  The May 4, 2009, letter instructed Ansell distributors to contact customers regarding return of affected product.  Ansell has not confirmed the information provided in the source material. 

Distributor: Designation:
Cardinal Health Reference No. FCA 2009123

 

  1. Action Needed: Verify that you have received the May 12, 2009, Urgent Product Recall letter and acknowledgment form from Cardinal Health and/or the May 4, 2009, letter from Ansell. Identify, isolate, and discontinue use of any affected product in your inventory. Regardless of whether you have any affected product, complete the acknowledgment form and return it to Cardinal Health by fax at (847) 689-9101. If your facility is located within the U.S., use the table below to contact the appropriate Cardinal Health customer service group to arrange for credit for affected product:  
    Facility Types: Cardinal Health Customer Service Telephone Nos.:
    U.S. Hospital (800) 964-5227
    U.S. Federal Government (800) 444-1166
    All Other U.S. Customers (888) 444-5440

      If you are located outside the U.S., contact your Cardinal Health local representative to arrange for credit for affected product.    

    For Further Information:
    Geographic Locations: Contacts: Telephone No.: Web Site:
    U.S. Cardinal Health professional services department (800) 292-9332 Click here
    Worldwide Cardinal Health local representative
    Ansell distributor
    Ansell local representative Click here

 

Source:

  • Letter submitted by ECRI Institute member hospital.

 

Comment:

  • This alert is a living document and may be updated when ECRI Institute receives additional information.  In circumstances in which we determine that it is appropriate for customers to repeat their review of an issue (e.g., when additional affected product has been identified), we will post a separate update alert.  In other cases, we may add information, such as additional commentary, recommendations, and/or source documents, to the original alert.

 

  • This alert is based on information that may not be independently verified as to its accuracy, completeness, or causal relationship to the product or its supplier.

 

  • The manufacturer has not confirmed the geographic distribution of affected product. ECRI Institute recommends that you check your inventory for this product regardless of where you are located.

 

Suggested Distribution: CSR/Materials Management, Emergency/Outpatient Services, Infection Control, Nursing, OR/Surgery

Verification History: One Member Submission[5/14/2009 11:24:09 AM]

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Seneca Medical—Ansell DermaPrene Ultra Surgical Gloves: May Experience Premature Degradation; May Tear during UseSuggested Distribution: CSR/Materials Management, Emergency/Outpatient Services, Infection Control, Nursing, OR/SurgeryDevice Term(s): Gloves, Surgical, Hypoallergenic [11-884]

Product Identifier: DermaPrene Ultra Surgical Gloves [Consumable] Catalog Nos.: 8512 through 8518 637 cases manufactured between October 22 and 23, 2008

 

Geographic Regions: (Impact in additional regions has not been identified or ruled out at the time of this posting), U.S.

Distributor: Seneca Medical Inc [139943], 85 Shaffer Park Dr PO Box 399, Tiffin, OH 44883, United States

Manufacturer: Ansell Healthcare Products LLC [365784], 200 Schulz Dr, Red Bank, NJ 07701, United States

See: Alert Accession No. A12254

Problem:   [May 14, 2009]  In the above-referenced alert, ECRI Institute reported that Ansell initiated a recall of the above gloves because they may have experienced premature degradation, potentially resulting in tearing during use. In a May 8, 2009, Product Recall letter submitted by an ECRI Institute member hospital, Seneca initiated a subrecall of the above gloves. To read the complete text from Alert Accession No. A12254, see below.  [May 14, 2009]   In a May 4, 2009, letter submitted by an ECRI Institute member hospital, Ansell states that recent data indicates that specific lots of the above gloves may have experienced premature degradation.  Use of the gloves could result in tearing during use.  The May 4, 2009, letter instructed Ansell distributors to contact customers regarding return of affected product.  Ansell has not confirmed the information provided in the source material.

 

Action Needed: Verify that you have received the May 8, 2009, Product Recall letter from Seneca.  Identify, isolate, and discontinue use of any affected product in your inventory.  Return unopened boxes of affected product to Seneca.  Seneca will issue credit for returned product.

For Further Information:
Geographic Location: Contacts: Web Sites:
Worldwide Seneca Medical local representative Click here 
Ansell distributor
Ansell local representative Click here

 

Source:

  • Letter submitted by ECRI Institute member hospital.

 

Comment:

  • This alert is a living document and may be updated when ECRI Institute receives additional information.  In circumstances in which we determine that it is appropriate for customers to repeat their review of an issue (e.g., when additional affected product has been identified), we will post a separate update alert.  In other cases, we may add information, such as additional commentary, recommendations, and/or source documents, to the original alert.
  • This alert is based on information that may not be independently verified as to its accuracy, completeness, or causal relationship to the product or its supplier.
  • The manufacturer has not confirmed the geographic distribution of affected product. ECRI Institute recommends that you check your inventory for this product regardless of where you are located.

 

Verification History: One Member Submission [5/14/2009 1:36:09 PM]

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R82—Posture Hip Belts Used with Buggies and Pediatric Seating Systems: May Not Tighten Correctly, Occupant May Slide Down in SeatDevice Term(s): Restraints, Wheelchair Occupant [13-356];Restraints, Wheelchair Occupant, Motor Vehicle [17-893]Product Identifier: Posture Hip Belts used with Buggies and Pediatric Seating Systems [Consumable, Capital Equipment] Batch Nos.: 85427-1, 85427-2, 85427-3, 85427-4, 85427-5 Belts manufactured in Taiwan between May 27 and August 31, 2008
 Geographic Regions: U.K.
Distributor: R82 UK Ltd [416471], Sterling Park, Woodgate Valley, Birmingham B32 3BU, England
Manufacturer: R82 A S [270604], Parallelvej 3, DK-8751 Gedved, Denmark
Problem: The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Medical Device Alert (MDA/2009/033) warning healthcare workers that the above belts were manufactured from webbing material that is too thin and could slip through the buckles during use. Consequently, if a belt extends to its maximum adjustment, the occupant could slide down in the seat and suffer positional asphyxiation. R82 initiated a field correction by Urgent Field Safety Notice letter dated September 3, 2008. The manufacturer has not confirmed the information provided in the source material. 

 

Regulatory Agency: Designations:
MHRA Reference Nos. MDA/2009/033, 2008/009/005/061/006

 
Action Needed: MHRA recommends that you identify any affected belts in your inventory. To assist in identifying the affected belts, the manufacturer has provided the following guidelines: 

  • Belts carrying a full label showing “Made in Taiwan” are affected.

 

  • Belts carrying a label showing “Made in Taiwan” with 1 bottom corner cut off are not affected because they were made from the correct material.

 

  • Belts carrying a label showing “Made in Denmark” are not affected.

  Contact R82 UK using the information below to obtain replacement belts. Arrange for the new belts to be fitted in accordance with the original instructions for use supplied with each seating system.  

 

For Further Information:
Geographic Locations: Contacts: Addresses: Telephone Nos.: Fax Nos.: E-Mail Addresses: Web Sites:
U.K. Sandy Evans, R82 UK Unit 4DA Coombswood Business Park East, Coombswood Way, Halesowen, West Midlands B62 8BH, England (0121) 5612222 (0121) 5615437 sev@r82.com  Click here
England Brian Mather or Jonathan Smith, Medicines & Healthcare Products Regulatory Agency Center for Assistive Technology, 241 Bristol Avenue, Bispham, Blackpool FY2 0BR, England (01253) 596000 (01253) 596177 brian.mather@mhra.gsi.gov.uk or jonathan.smith@mhra.gsi.gov.uk, respectively Click here
Northern Ireland Northern Ireland Adverse Incident Center Health Estates, Estate Policy Directorate, Stoney Road, Dundonald, Belfast BT16 1US (02890) 523704 (02890) 523900 NIAIC@dhsspsni.gov.uk Click here
Scotland Incident Reporting and Investigation Center Health Facilities Scotland, NHS National Services Scotland, Gyle Square, 1 South Gyle Crescent, Edinburgh EH12 9EB (0131) 2757575 (0131) 3140722 iric@shs.csa.scot.nhs.uk Click here
Wales National Assembly for Wales HIMTE 3 Division, NHS Directorate, Cathays Park, Cardiff CF10 3NQ (0292) 0823373 (0292) 0825479 Haz-Aic@wales.gsi.gov.uk None listed

All inquiries to MHRA should quote reference nos. MDA/2009/033 or 2008/009/005/061/006.
 
Source:

  • Great Britain. Medicines and Healthcare Products Regulatory Agency. Posture (hip) belts for use on paediatric seating systems and buggies. Manufactured and supplied by R82 between 27 May 2008 and 31 August 2008 [online]. London: Department of Health; 2009 May 11 [cited 2009 May 12]. 5 p. (Medical device alert; no. MDA/2009/033). Available from Internet: Click here.

 
Comment:

  • This alert is a living document and may be updated when ECRI Institute receives additional information.  In circumstances in which we determine that it is appropriate for customers to repeat their review of an issue (e.g., when additional affected product has been identified), we will post a separate update alert.  In other cases, we may add information, such as additional commentary, recommendations, and/or source documents, to the original alert.

 

  • This incident report is based on information supplied to MHRA that may not be independently verified as to its accuracy, completeness, or causal relationship to the product or its supplier.

 

 

 
 
Suggested Distribution: Clinical/Biomedical Engineering, CSR/Materials Management, Facilities/Building Management, Home Care, Nursing, Pediatrics, Physical Therapy/Rehabilitation, Staff Education
Verification History: Alert Confirmed by Non-U.S. Regulatory Agency[5/11/2009 4:21:25 PM]

MSA—Eaton Aeroquip Quick-Fill System and Universal Rescue Connection Male Coupling Air Mask Components: May Be Unable to Connect; May Leak while ConnectedDevice Term(s): Fittings/Adapters, Pneumatic, Quick-Connect [11-731];

Masks, Chemical/Biological Agent Protection [20-702]

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