GelPOINT Path Transanal Procedural Pack with Epix recall
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The…
Why was GelPOINT Path Transanal Procedural Pack with Epix recalled?
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: TA211 Lot Numbers: 1342169 and 1340118
- Product
- GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The…
- Recalling firm
- Applied Medical Resources Corp
- Quantity
- 39 units Domestically and 112 units Internationally
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
- Recall date
- November 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)