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Recall Observatory FDA recall evidence

Device product

LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.

Z-2545-2019

August 19, 2019

Class III

Product summary

Firm
CooperSurgical, Inc.
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

    reason.no_named_rule · v1.0.0

    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.