Recall Z-3164-2024 ยท GCJ Laparoscope, General & Plastic Surgery
UNIMAX MEDICAL SYSTEMS INC
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP9790
| Date | Sep 17, 2024 (initiated Jun 25, 2024) |
| Status | Open, Classified |
| Reason | The tube may fall into the surgical site during the grasping process. |
| Root cause | Device Design |
| Action | The recalling firm issued letters dated 6/25/2024 to two distributors and dated 6/27/2024 to one distributor. The letters were issued via email beginning 6/25/2024. The letter provided the reason for recall and the actions to be taken, which included: (1) Identify the affected devices at your facility and complete the Acknowledgement and Receipt Form; (2) Distribute the notification to relevant people/facilities to where the affected lots have been distributed. (3) Quarantine the affected devices and implement the destruction after receiving confirmation from UNIMAX. A list of catalog numbe |
| Quantity | 81,241 endo retrieval pouches |
| Distribution | US Nationwide distribution in the states of GA, MO, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103510 | UNIMAX SPECIMEN RETRIEVAL SYSTEM Unimax Medical Systems, Inc., May 6, 2011 |