Recall Z-0691-2017 ยท LRS I.V. Start Kit
B. Braun Medical, Inc.
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
| Date | Jul 29, 2016 |
| Status | Terminated |
| Reason | Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot. |
| Root cause | Unknown/Undetermined by 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 |
| Quantity | 15,950 units |
| Distribution | Nationwide Distribution to GA, IL, and FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.