Reported Apr 26, 2017 · Terminated
Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to…
Avid Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Avid Medical, Inc. · 9000 Westmont Dr · Toano, VA · 23168-9351
Is this the product you have?
- Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.
- Lot codes and dates
- Part Number/Product NumberPart Number/Product Number
ILEY029-01ULKY005-14LOUS015-03DNAZ017-01ILEY029-02SERA003-07TENN016-05DONS008-05EVER007SERA005-07LANC029-06STLM007-10CCHM024-03
Part Number/Product NumberLANC015-27CCHM027-04STLM003-11ABIN137-01ABIN110-01LANC015-28MONT045-03ILEY003-53NAFB015-07ILEY014-21ILEY034-04ILEY034-05
Part Number/Product NumberAV10654-10ILEY014-22EVER010EVER001SOHS016-03SSHH118-03SSHH117-06SOHS017-03HCMH009-05WIME023-08TUFT040-05
TUFT039-08HCMH009-06GIFT022-01TUFT040-06PCHM004-07HLDH008-04WHWC005-17PCHM008-04LANC015-25PCHM011-03
- Part Number/Product Number
- Amount recalled
- 25308
Why it was recalled
Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer component 519700 (BD: 367863) expiring 12/16 was discovered inside of a kit labelled with an expiration date after 12/16. Upon receipt of complaint, AVID Medical promptly initiated an internal investigation and root cause analysis. Investigation found mixed component lots were contained in product 519700 component case. This occurrence resulted in the incorrect lot number and expiration being attributed to all work orders produced using the affected component. This issue was immediately contained and corrected. A full inventory analysis was conducted reviewing all vacutainer component inventories. The issue was found to affect a total of five vacutainer components.
This product could cause temporary or reversible health problems — stop using it.
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