FDA DevicesClass II
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number:...
Published: July 8, 2026Recall ID: Z-2654-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Product Description & Identification
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
Affected 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
Additional Source Details
| Field | Value |
|---|---|
| City | Eysins |
| State | N/A |
| Event id | 99085 |
| Address 1 | Terre Bonne Park A4 |
| Address 2 | Route De Crassier 17 |
| Code info | Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445 |
| Postal code | N/A |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 50 devices |
| Reason for recall | Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260604 |
| Initial firm notification | N/A |
| Center classification date | 20260702 |
Overview
- Recalling FirmBD SWITZERLAND SARL
- StatusOngoing
- Risk LevelClass II
- DistributionU.S.: IL O.U.S: N/A