Device product
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
Z-2545-2019
Product summary
- Event
- Event 83704
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4930 units
- Official record key
device-enforcement:Z-2545-2019
Official wording
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.
Code information: Lot # 201809125 & 201809135
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
Derived failure modes
-
Unknown
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.