Z-2112-2020 Class II Terminated
FDA device recall Z-2112-2020 was initiated by CooperSurgical, Inc. on April 9, 2020 and is designated Class II. Reason for recall: The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators. The recall status is terminated (terminated May 11, 2021). Affected quantity: 1740 units/174 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 9, 2020
- Termination Date
- May 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1740 units/174 boxes
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.
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
Code Information
Lot # 257589