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Terminated

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

FDA Recall Z-0691-2017 · Posted None

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeLRS
Date Initiated2016-07-29
Date Terminated2018-03-06
Product Quantity15,950 units

Reason for Recall

Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

Firm Action

BBMI (B. Braun) provided written notification on August 05, 2016, to all BBMI customers in receipt of the suspected product. These customers included both BBMI direct end customers and BBMI direct distributors. Customers were asked to determine if they had the affected lots in their possession. If they did, customers were asked not to destroy the product and to immediately discontinue use of and quarantine if found. Customers were also asked to complete the Product Removal Acknowledgement form and return to B. Braun. B. Braun will contact each customer if they have any full cases, partial cases or unused pieces of the affected products to provide instructions for handling and return of the affected products. Customers with questions were instructed to call 1-800-227-2862.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Nationwide Distribution to GA, IL, and FL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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