Wilson-Cook Recalls Acusnare Polypectomy Snares Due to Loop Retraction Issues
Wilson-Cook Medical Inc. is recalling 34,456 Acusnare Polypectomy Snares because the snare loop may not completely retract or may misshape.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves a functional defect in a medical device used during surgery, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Wilson-Cook Medical Inc. is recalling 34,456 units of the Acusnare Polypectomy (Duck Bill Shaped) Snare. The device is used with an electrosurgical unit for endoscopic polypectomy. The recall covers specific lot numbers identified in the agency's structured data.
The recall was initiated due to complaints that the snare loop does not completely retract and/or that the snare loop misshapes. These defects could affect the device's performance during endoscopic procedures.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected devices.
The recalled product
- Product
- Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
- Manufacturer
- Wilson-Cook Medical Inc.
- Affected units
- 34,456
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)
- ASDB-15-015- S with Lot #'s W4010785
- W4010787
- W4010788
- W4010789
- W4010791
- W4010792
- W4010793
- W4010794
- W4010795
- W4010796
- W4010797
- W4010799
- W4010801
- W4010802
- W4010803
- W4010804
- W4010805
- W4010806
- W4012291
- W4012292
Distribution
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