Recall Z-2112-2020— CooperSurgical, Inc.

Name: FDA recall Z-2112-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-09

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2020-04-09, terminated 2021-05-11. It names one FDA 510(k) clearance: K183020. Product: CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21. Reason: The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-04-09
Terminated: 2021-05-11
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K183020 — Endosee SystemCooperSurgical, Inc.·cleared 2019-01-31

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

CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

Reason for recall

The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.

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