Recall Z-0258-2022— CooperSurgical, Inc.

Name: FDA recall Z-0258-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-29

Class II · Ongoing

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2021-09-29. It names one FDA 510(k) clearance: K963348. Product: LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220. Reason: Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-09-29
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K963348 — WALLACH INTEGRATION UNITWallach Surgical Devices, Inc.·cleared 1997-03-19

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 PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220

Reason for recall

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

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