FDA-Device2026-07-08Class II
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
Hazard
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
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 SWITZERLAND SARL recalls
- FDA-Device2026-06-24BD Connecta BD Luer-Lok 360 stopcock recalled for loose Port C connection
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