Applied Medical Recalls GelPOINT Path Transanal Procedural Packs Due to Insulation Shift
Applied Medical Resources Corp is recalling GelPOINT Path Transanal Procedural Packs because the tip insulation on the electrosurgical probes may shift unintentionally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, and the defect involves the shifting of insulation on electrosurgical probes, which presents a significant risk of electrical injury or burn to the patient during a procedure.
Plain-English summary
Applied Medical Resources Corp is recalling the GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm (REF TA211). The recall is due to a defect where the tip insulation of the electrosurgical probes may shift unintentionally.
The affected products are identified by Model Number TA211 and Lot Numbers 1342169 and 1340118. A total of 39 units were distributed domestically and 112 units were distributed internationally. The products were distributed in the United States and in Belgium, Germany, Switzerland, Spain, Finland, France, Great Britain, Israel, India, Italy, Lebanon, Netherlands, and Portugal.
The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures. Users should contact Applied Medical Resources Corp for further instructions regarding the recall.
The recalled product
- 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 GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform variou
- Manufacturer
- Applied Medical Resources Corp
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 (1)
- Model Number: TA211 Lot Numbers: 1342169 and 1340118
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Applied Medical Resources Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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