Recall Z-1642-2015 ยท GCJ Laparoscope, General & Plastic Surgery
DeRoyal Industries Inc
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.
| Date | May 21, 2015 (initiated Apr 17, 2015) |
| Status | Terminated |
| Reason | The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use. |
| Root cause | Device Design |
| Action | DeRoyal sent an Urgent: Voluntary Recall letter dated April 17, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Check your inventory for the product and specific lot number from the attached Recall Response Form. 2. If you have affected inventory, please destroy it and dispose of it according to your facilitys procedures. 3. Record all information on the included Recall Response and Notice of Destruction forms. 4. If you purchase through a distributor, please indicate their name/location on the Notice of D |
| Quantity | 5359 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132375 | GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG Genicon, Jun 12, 2014 |