UNIMAX MEDICAL SYSTEMS INC recalls 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services I…
- Recall date
- June 25, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3164-2024
- FDA classification
- Class II
- Brand / firm
- UNIMAX MEDICAL SYSTEMS INC
- Sold / distributed
- US Nationwide distribution in the states of GA, MO, and PA.
Why it was recalled
The tube may fall into the surgical site during the grasping process.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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;
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