Bd Switzerland Sarl: Medline 111 Gravity Set W/3 Needle Free Y-sites Ref Dyndtn0555
Recall Summary Medline 111 Gravity Sets with 3 Needle Free Y-Sites (catalog number SAM2461) distributed in Illinois have been recalled because engineering samples labeled "Not for Human Use" were accidentally shipped to the U.S. market instead of approved products. This is classified as a Class II recall by BD Switzerland SARL.
- Recalling firm
- BD SWITZERLAND SARL
- Product
- 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
- Reason
- Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-04
- Status
- Ongoing
- Areas affected
- IL
- Distribution
- U.S.: IL O.U.S: N/A
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/ebc08cff-34bf-4d09-a883-e2881d2fa216