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;
FDA Recall Z-3164-2024 · Posted 2024-09-17
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Recalling FirmUNIMAX MEDICAL SYSTEMS INC
Recall StatusOpen, Classified
Product CodeGCJ
Date Initiated2024-06-25
Product Quantity81,241 endo retrieval pouches
Reason for Recall
The tube may fall into the surgical site during the grasping process.
Firm 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 numbers and lot numbers was enclosed.
If the consignee had the affected product, they were to list the catalog number, lot number, and quantity in their possession on the Acknowledgement and Receipt Form. They were to also indicate whether they have notified the relevant person/facility to where the affected lot had been distributed and indicate they have quarantined the affected devices for destruction. The form was to be emailed to the recalling firm.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of GA, MO, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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