CooperSurgical Wallach Loop Electrode recalled for incorrect packaging
CooperSurgical has recalled its Wallach Loop Electrodes (Lot 274420) due to incorrect packaging. Packages labeled as Square Electrodes contained Round Electrodes instead, creating a risk of improper device use in surgical procedures.
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: FDA Class II recall involving a packaging error where the wrong electrode type was included in labeled packaging. Use of an incorrect electrode shape in surgical procedures represents a risk of harm, though no injuries have been reported.
Plain-English summary
CooperSurgical, Inc. is recalling Wallach Loop Electrodes 10mm x 10mm Square (Part Number 909131, Lot 274420). These electrodes are disposable devices used for electro-excisional and electro-fulguration procedures of the lower genital tract.
The recall was initiated because the affected electrodes were incorrectly packaged with a Round Electrode inside packages labeled as Square Electrodes. This packaging error creates a risk that healthcare providers could use the wrong electrode type during procedures.
The recall affects 20 boxes of 5 electrodes each that were distributed to facilities in California, Maryland, Missouri, New Jersey, Pennsylvania, and Texas.
The recalled product
- Product
- CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract
- Manufacturer
- CooperSurgical, Inc.
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)
- Lot 274420
Distribution
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