Recall Z-2545-2019 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
CooperSurgical, Inc.
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
| Date | Aug 19, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by 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 recall@coopersurgical.com. |
| Quantity | 4930 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120476 | MACROLYTE DISPERSIVE ELECTRODE Conmed Corporation, Jun 12, 2012 |