| Class 2 Device Recall Detachable Endo Pocket |  |
Date Initiated by Firm | June 25, 2024 |
Date Posted | September 17, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-3164-2024 |
Recall Event ID |
95133 |
510(K)Number | K103510 |
Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
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Product | 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; |
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.
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Recalling Firm/ Manufacturer |
UNIMAX MEDICAL SYSTEMS INC 8F-2, NO 127, LANE 235, PAO CHIAO RD Hsin Tien Taiwan
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Manufacturer Reason for Recall | The tube may fall into the surgical site during the grasping process. |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 81,241 endo retrieval pouches |
Distribution | US Nationwide distribution in the states of GA, MO, and PA. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = GCJ
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