—#149990

Product

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

FDA product code: LRS — I.V. Start Kit
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lot Number 361105, exp date 1/01/2017, Product Catalog Number 375198

Why it was recalled

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

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Nationwide Distribution to GA, IL, and FL

Timeline

Recall initiated: 2016-07-29
Terminated: 2018-03-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149990. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.