Device product
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Z-1382-2024
Product summary
- Event
- Event 94129
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 134 tracecarts
- Official record key
device-enforcement:Z-1382-2024
Official wording
Reason: DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
Code information: a) 53-1831 ORTHO TOTAL JOINT TRACECART, GTIN 0749756598088, Lot Numbers: 57587017 exp 2/1/2024, 57760377 exp 2/1/2024, 58185167 exp 5/1/2024, 58628933 exp 6/1/2024, 58834059 exp 9/1/2024, 58864266 exp 7/1/2024, 59223364 exp 7/1/2024, 59355050 exp 2/1/2025, 59548003 exp 5/1/2025; b) 53-1836 GENERAL SURGERY TRACECART, GTIN 0749756598132, Lot Numbers: 58654875 exp 6/1/2024, 58736096 exp 6/1/2024, 59146688 exp 7/1/2024, 59223356 exp 7/1/2024, 59443367 exp 11/1/2024, 59510136 exp 11/1/2024, 59515455 exp 3/1/2025, 59661866 exp 5/1/2025
Distribution pattern: Florida
Derived failure modes
-
Unknown
DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.