BacT/ALERT Blood Collection Adapter The BacT/ALERT Adapter Cap is intended for use as an aid to facilitate filling of bl

FDA device recall Z-1336-2012 · posted 2012-03-30 · Terminated

Recall details

Recalling firm

bioMerieux, Inc.

Reason for recall

The BacT/ALERT Blood Collection Adapter Cap is no longer compatible with Becton Dickinson (BK) Vacutainer Safety Lok Blood Collection Set. The incompatibility is the blood collection set needle backing out of the adapter cap that results in an exposed sheathed needle that may lead to an accidental needlestick.

Action taken

bioMerieux sent an Urgent Product Correction Notice letter dated March 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: 1. Ensure the letter and guidance on how to maintain control of the luer connector by securing it between the thumb and forefinger are distributed to all appropriate personnel within their organization. 2. Fill out and return the Acknowledgement Form by Fax to confirm receipt of the recall notice. For additional assistance or questions customers were instructed to contact their local bioMerieux Customer Service Representative at (800) 682-2666, option 3, then option 3 again. Industry customers should call 800- 634-7656, option 3. For questions regarding this recall call 314-731-8537.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GIM

Quantity affected

274,800 boxes (32,862,600 caps)

Distribution

Worldwide Distribution - USA (nationwide), Australia, Brazil, Canada, Chile, Columbia, Costa Rica, France, China, Indonesia, Korea, Mexico, Peru, Singapore, Ecuador, Dominican Republic, Philippines, G

Date initiated

2012-03-05

Date posted

2012-03-30

Date terminated

2014-09-04

Location

Durham, NC

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