Endo Retrieval Pouches Recalled; Tube May Detach During Endoscopic Use
Endo retrieval pouches are recalled because the tube may detach and fall into the surgical site during use. Approximately 81,241 units distributed in Georgia, Missouri, and Pennsylvania are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical device with a mechanical defect where the tube may detach during use. While no injuries have been reported, the potential for device failure to cause the component to fall into the surgical site represents a significant risk of harm during a critical procedure.
Plain-English summary
UNIMAX Medical Systems Inc. is recalling detachable endo retrieval pouches sold under the Tech Medical Services, UNIMAX, and ConMed brand names. These sterile surgical pouches are used in endoscopic procedures and come in multiple sizes. Approximately 81,241 units are included in this recall.
The pouches have a defect where the tube may detach and fall into the surgical site during the grasping process.
The recalled products were distributed in Georgia, Missouri, and Pennsylvania. Specific lot numbers and product reference codes are detailed in the FDA recall notice. Healthcare providers and facilities should immediately discontinue use of the affected products and contact the manufacturer for replacement or disposal instructions.
The recalled product
- 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", s
- Manufacturer
- UNIMAX MEDICAL SYSTEMS INC
- Hazard
- detachment
- foreign-body
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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