Recall Z-0937-2020 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490314
| Date | Nov 20, 2019 |
| Status | Terminated |
| Reason | Potential for leakage at the joint between the blood filters and tubing |
| Root cause | Nonconforming Material/Component |
| Action | On 11/20/2019, B Braun Medical Inc. issued Urgent Medical Device letters and Product Removal Acknowledgment forms to customers. On 11/20/2019, B Braun Medical Inc. also issued a press release. Actions Required By BBMI Customer/User: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward a copy of the recall notification to your customers. 2. Determine your current inventory of the affected lots with |
| Quantity | 5,616 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK Elcam Medical Acal, Apr 13, 2006 |
| K083723 | A6 LUER ACCESS DEVICE B.Braun Medical, Inc., Jun 5, 2009 |
| K140311 | CARESITE LUER ACCESS DEVICE B.Braun Medical, Inc., May 7, 2014 |
| K840212 | CONCENTRATED PLATELET ADMIN. SET American Mcgaw, Mar 6, 1984 |
| K922637 | HORIZON PUMP Y-TYPE BLOOD SET Mcgaw, Inc., Jun 4, 1993 |