Recall Z-2654-2026 ยท FPA Set, Administration, Intravascular
BD SWITZERLAND SARL
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
| Date | Jul 2, 2026 (initiated Jun 4, 2026) |
| Status | Open, Classified |
| Reason | Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market. |
| Root cause | Under Investigation by firm |
| Action | On 06/04/2026, the firm email an "URGENT: MEDICAL DEVICE CORRECTION" Letter informing customers that BD is recalling Engineering Samples labelled Not for Human Use listed above that were inadvertently shipped to the U.S. market. Customers are instructed to: 1. Cease use and destroy any unused affected product listed in the table above according to your facilities regulations. 2. Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 3. Complete the attached Customer Response For |
| Quantity | 50 devices |
| Distribution | U.S.: IL O.U.S: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.