LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
- Company
- Coopersurgical, Inc.
- Recall Initiated
- August 19, 2019
- Terminated
- July 14, 2020
- Recall Number
- Z-2545-2019
- Quantity
- 4930 units
- Firm Location
- Trumbull, CT
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.
Distribution
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
Lot / Code Info
Lot # 201809125 & 201809135
Root Cause
Under Investigation by firm
Action Taken
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 recall@coopersurgical.com.