FDA Enforcement
Class II
Terminated
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.
Recall: Z-1642-2015
·
Reported May 27, 2015
Enforcement
- Recall Number
- Z-1642-2015
- Event ID
- 71193
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- DeRoyal Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 27, 2015
- Initiation Date
- April 17, 2015
- Classification Date
- May 21, 2015
- Termination Date
- December 29, 2015
- Address
- 200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States
Description
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.
Reason
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
Code Info
1211QDA403, 1301QDA402, 1301QDA410, 1303QDA401, 211QDA403, 32046564, 32119911, 32338381, 32562251, 32783812, 32886441, 32891051, 32899882, 32942609, 33114274, 34939294, 35229930, 35579999, 35738515
Distribution
US Nationwide Distribution
Quantity
5359 units