UNIMAX MEDICAL SYSTEMS INC: Device Recall
Recall #Z-3164-2024 · 06/25/2024
Recall Details
- Recall Number
- Z-3164-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- UNIMAX MEDICAL SYSTEMS INC
- Status
- Ongoing
- Date Initiated
- 06/25/2024
- Location
- Hsin Tien, Taiwan
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81,241 endo retrieval pouches
Reason for Recall
The tube may fall into the surgical site during the grasping process.
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;
Distribution Pattern
US Nationwide distribution in the states of GA, MO, and PA.