Z-3164-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2024
- Initiation Date
- June 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81,241 endo retrieval pouches
Product Description
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 FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;
Reason for Recall
The tube may fall into the surgical site during the grasping process.
Distribution Pattern
US Nationwide distribution in the states of GA, MO, and PA.
Code Information
1. REF TM2001 - Lot numbers 6252207033, 6252211139, and 6252304152, UDI-DI 00851695005104; 2. REF TM2000 - Lot numbers 6252207032, 6252211138, and 6252304151, UDI-DI 00851695005098; 3. REF TM2002 - Lot numbers 6252207034, 6252211140, and 6252304153, UDI-DI 00851695005111; 4. REF FEP936116 - Lot number 6252303126, UDI-DI 04714127863504; 5. REF FEP979000 - Lot number 6252207216, UDI-DI 04714127863573; 6. REF SB936 - Lot numbers 6252207165, 6252207184, 6252207186, 6252304017, 6252304033, 6252305036, 6252305087, UDI-DI 0471412786076; 7. REF SB957 - Lot numbers 6252207180, 6252211177, 6252211178, 6252303004, 6252303018, 6252304025, 6252304034, 6252304046, UDI-DI 04714127860770; 8. REF SB979 - Lot numbers 6252207022, 6252207182, 6252303007, 6252303017, 6252304026, 6252304035, 6252304047, UDI-DI 04714127860909; 9. REF SB979-CA - Lot numbers 6252212124, 6252207201, 6252209205, UDI-DI 04714127861395; 10. REF SB936-CA - Lot number 6252212017, UDI-DI 04714127861371.