August & September 2009 Alerts

St Jude—7 Fr and 9 Fr Peel-Away Introducers: Outer Carton May Be Mislabeled

Device Term(s): Needles, Catheter Introduction [20-244]

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Peel-Away Introducers:	Reference Nos.:	Lot Nos.:	No. of Units Distributed:
(1) 7 Fr	(1) 405153	(1) 2694252	(1) 200
(2) 9 Fr	(2) 405116	(2) 2694227	(2) 200

 

  

[Consumable]

 

Geographic Regions: Europe

Manufacturer: St Jude Medical Inc [452237], 14901 DeVeau Pl, Minnetonka, MN 55345-2126, United States

 

 

Regulatory Agency:	Designation:
FDA	Class II Recall Nos. Z-1713/1714-2009

 

United States:

• Food and Drug Administration. Center for Devices and Radiological Health. Medical device recalls: Class 2 recall—SJM Peel Away introducer [online]. 2009 Aug 17 [cited 2009 Aug 26]. Available from Internet: Click here.
• Food and Drug Administration. Center for Devices and Radiological Health. Medical device recalls: Class 2 recall—SJM Peel Away introducer [online]. 2009 Aug 17 [cited 2009 Aug 26]. Available from Internet: Click here.
• United States. FDA Enforcement Rep [online]. 2009 Aug 26 [cited 2009 Aug 27]. Available from Internet: Click here.

Manufacturer.

 

• 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: Cardiology/Cardiac Catheterization Laboratory, Critical Care, CSR/Materials Management, Emergency/Outpatient Services, OR/Surgery

Verification History: Alert Confirmed by FDA[8/26/2009 9:44:15 AM]; Alert Confirmed by Mfr./Dist.[8/27/2009 9:32:49 AM]; Fully verified[8/27/2009 9:32:50 AM]

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Advanced Sterilization Products—STERRAD CYCLESURE and CYCLESURE 24 Biological Indicators: Manufacturer Issues New Instructions for Use

Device Term(s): Sterilization Process Indicators, Biological [13-732]

Product Identifier: STERRAD Biological Indicators: (1) CYCLESURE, (2) CYCLESURE 24 [Consumable]

Geographic Regions: Worldwide

Manufacturer: Advanced Sterilization Products, A Division of Ethicon, Inc. A Johnson & Johnson Co [186653], 33 Technology Dr, Irvine, CA 92618, United States

Problem: In an August 19, 2009, Important Product Labeling Correction letter submitted by ECRI Institute member hospitals, Advanced Sterilization Products (ASP) states that the above indicators may exhibit the following problems:  (1) The media may evaporate over time. Evaporation may be accelerated if the vial cap is not fully depressed before incubation. Additionally, a small number of vials undergoing incubation may evaporate within the currently-labeled maximum incubations time of 5 days, even if instructions are followed. Continued incubation >72 hr may result in evaporation of the media, making an accurate reading impossible.  (2) The media may experience a color shift; the yellow result from a positive test may gradually shift to lighter shades of yellow or gray with continued incubation >72 hr. The color shift may make the above indicators more difficult to read, potentially resulting in an incorrect reading.   ASP is reducing the maximum read time for the above media to 72 hr (3 days) and has revised the instructions for use to avoid these problems.

 

Action Needed: Verify that you have received the August 19, 2009, Important Product Labeling Correction letter and revised instructions for use from ASP. Identify any affected product in your facility. Refer to and follow the revised indicator instructions for use. Forward a copy of the Important Product Labeling Correction letter and revised instructions for use to any relevant staff. Always verify any negative results by direct color comparison to the negative control and by observing for turbidity. ASP recommends that you compare the color to the positive control indicator (for yellow) and the negative control indicator (for purple). ASP recommends that you hold the indicators against a white background to better differentiate the colors. Based on the updated instructions, the CYCLESURE biological indicators 48 hr incubation product) requires a minimum incubation time of 48 hr for read out but not >72 hr.

For Further Information:
Geographic Locations:	Contacts:	Telephone No.:	Web Site:
U.S.	ASP customer care center	(888) 783-7723 (select option 3, then option 2), between 6:30 a.m. and 4:00 p.m. Pacific time Monday through Friday	Click here
Outside the U.S.	ASP local representative

 

Source:

• Letters submitted by ECRI Institute member hospitals.
• 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, Infection Control, OR/Surgery

Verification History: Two or More Member Submissions[8/26/2009 11:57:09 AM]; Alert Confirmed by Mfr./Dist.[8/26/2009 12:00:42 PM]; Fully verified[8/26/2009 12:00:45 PM]

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ConMed Linvatec—Lightwave Suction Ablators: May Not Shut Off When the Ablate Button Is Released

Device Term(s): Electrodes, Electrosurgical, Active, Hand-Controlled [11-499]

Catalog No. IA-200-S; Expiration Dates: JUL 2009 through SEP 2013

 

Geographic Regions: Worldwide

Manufacturer: ConMed Linvatec A ConMed Co [451026], 11311 Concept Blvd, Largo, FL 33773, United States

Problem: In an August 12, 2009, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, ConMed Linvatec states that the above devices may not shut off if the ablate button is released, possibly causing patient or user injury.  The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and the German Federal Institute for Drugs and Medical Devices (BfArM) posted an Urgent Medical Device Recall letter dated August 4, 2009.

Regulatory Agencies:	Designations:
MHRA	Reference No. 2009/008/010/291/012; may issue further advice
BfArM	Reference No. 3004/09

 

 

 

For Further Information:
Geographic Region:	Contacts:	E-Mail Address:	Web Sites:
Worldwide	ConMed Linvatec customer service department	Custserv@linvatec.com	Click here
	ConMed Linvatec local representative		Click here

Device Term(s): Capnometers, Exhaled Gas [20-729];

Detectors, Esophageal Intubation, Exhaled Carbon Dioxide [17-614]
 
Product Identifier:

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End-Tidal CO2 Detectors:	Cardinal Health Catalog Nos.:
(1) PediCap	(1) NPEDICAP
(2) PediCap 6	(2) PEDICAP-6

[Consumable]

Lot Nos.: (1 and 2) 8294199, 8301112, 8301113, 8315189, 8315190, 8319262, 8319263, 8322181, 8322182, 8326251, 8326252, 8326253, 8326254, 8329072, 8329073, 8330001, 8333183, 8350018, 8350019, 8354221, 8354224, 8357021, 8357022, 8361153, 9005011, 9005012, 9012058, 9012059, 9026042, 9026043, 9033128, 9033129, 9040067, 9040068, 9047127, 9047128, 9054110, 9054111, 9061066, 9061067, 9065209, 9068061, 9068062, 9072281, 9075059, 9075060, 9079160, 9082376, 9082377, 9086312, 9089126, 9089127, 9103038, 9103039, 9110481, 9110482, 9117039, 9117040, 9124134, 9124135, 9131188, 9131189, 9138084, 9138085, 9138226, 9145088, 9145089, 9152238, 9152239, 9159128, 9159129, 9170191, 9170192, 9170197, 9176471, 9176477, 9184145, 9191233, 9191234, 9204128

Units distributed between November 1, 2008, and July 24, 2009