LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
FDA Recall Z-2545-2019 · Posted None
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Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2019-08-19
Date Terminated2020-07-14
Product Quantity4930 units
Reason for Recall
Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed.
Firm Action
Firm sent letter 8/19/2019.
1. Please discard the outer master 10- pack box containing barcode label .
2. Keep the individual seal pouches with correct expiration date.
3. Complete and return the acknowledgement and receipt form.
4. To return the product, Qurantine the affected product, complete and retun the acknowledegment and receipt form to CooperSurgical.
If you have additional questions, please contact a CooperSurgical Product Surveillance representative at 203.601.5200 Ext. 3300 or email us at [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
USA: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, & WV. Distribution US nationwide, Canada, Colombia, Japan, & Malaysia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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