Z-2545-2019 Class III Terminated
FDA device recall Z-2545-2019 was initiated by CooperSurgical, Inc. on August 19, 2019 and is designated Class III. 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. The recall status is terminated (terminated July 14, 2020). Affected quantity: 4930 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2019
- Initiation Date
- August 19, 2019
- Termination Date
- July 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4930 units
Product Description
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
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 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
Code Information
Lot # 201809125 & 201809135