1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services In
FDA device recall Z-3164-2024 · posted 2024-09-17 · Open, Classified
Recall details
- Recalling firm
- UNIMAX MEDICAL SYSTEMS INC
- Reason for recall
- The tube may fall into the surgical site during the grasping process.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- GCJ
- Quantity affected
- 81,241 endo retrieval pouches
- Distribution
- US Nationwide distribution in the states of GA, MO, and PA.
- Date initiated
- 2024-06-25
- Date posted
- 2024-09-17
- Location
- Hsin Tien, Taiwan
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNIMAX SPECIMEN RETRIEVAL SYSTEM (K103510) | Unimax Medical Systems, Inc. | 2011-05-06 |