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

Recall date

August 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2545-2019

FDA classification

Class III

Brand / firm

CooperSurgical, Inc.

Sold / distributed

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

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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