Device product
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
Z-1642-2015
Product summary
- Event
- Event 71193
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5359 units
- Official record key
device-enforcement:Z-1642-2015
Official wording
Reason: The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
Code information: 1211QDA403, 1301QDA402, 1301QDA410, 1303QDA401, 211QDA403, 32046564, 32119911, 32338381, 32562251, 32783812, 32886441, 32891051, 32899882, 32942609, 33114274, 34939294, 35229930, 35579999, 35738515
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.