FDA-Device2026-07-08Class IIMISBRANDING
BD Switzerland Medline 111 gravity set recalled — engineering sample shipped in error
What this means
BD Switzerland inadvertently shipped 50 engineering sample units of the Medline 111 Gravity Set with 3 Needle Free Y-Sites into the U.S. market. These units were labeled "Not for Human Use" and were not intended for patient care. No injuries have been reported.
- If you received or are using catalog number SAM2461 (Lot 25X445), stop using it immediately.
- Contact your supplier or BD Switzerland to return the device.
- Do not use this product on patients.
The agency's original wording
Hazard
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.: IL O.U.S: N/A
Affected count
50 devices
Manufactured in
Terre Bonne Park A4, Route De Crassier 17, Eysins, N/A, Switzerland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2654-2026More BD recalls
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