Device product
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Z-2112-2020
Product summary
- Event
- Event 85544
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1740 units/174 boxes
- Official record key
device-enforcement:Z-2112-2020
Official wording
Reason: The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Code information: Lot # 257589
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
Derived failure modes
-
Unknown
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.