CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
FDA Recall Z-2112-2020 · Posted None
Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHIH
Date Initiated2020-04-09
Date Terminated2021-05-11
Product Quantity1740 units/174 boxes
Reason for Recall
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Firm Action
CooperSurgical sent an Urgent Medical Device Recall letter dated April 9, 2020 to all customers that received lot number 257589 of the Milex Cervical Dilator P/N MX21 which could have a compromised finished seal (opposite the chevron seal) of the sterile pouch. Customers were instructed to inspect each package for damage, including the seal area, prior to use (product is acceptable for use if it is visually confirmed that the pouchs seal is intact). Customers should discontinue use of and quarantine products with any packaging irregularities. The firm requested that the customers complete and return the attached Acknowledgement and Receipt Form, whether or not they had any of the affected product on hand. CooperSurgical stated that they will arrange for product returns and replacement.
Root Cause
Packaging process control
Distribution Pattern
Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.