Recall Z-2545-2019— CooperSurgical, Inc.

Name: FDA recall Z-2545-2019
Creator: U.S. Food and Drug Administration
Published: 2019-08-19

Class III · Terminated

Class III FDA medical device recall by CooperSurgical, Inc., initiated 2019-08-19, terminated 2020-07-14. It names one FDA 510(k) clearance: K120476. Product: LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.. 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..

Recalling firm: CooperSurgical, Inc.
Classification: Class III
Status: Terminated
Initiated: 2019-08-19
Terminated: 2020-07-14
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K120476 — MACROLYTE DISPERSIVE ELECTRODEConmed Corporation·cleared 2012-06-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.