Recall Z-2112-2020 ยท HIH Hysteroscope (And Accessories)
CooperSurgical, Inc.
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
| Date | Apr 9, 2020 |
| Status | Terminated |
| Reason | The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators. |
| Root cause | Packaging process control |
| 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 |
| Quantity | 1740 units/174 boxes |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183020 | Endosee System CooperSurgical, Inc., Jan 31, 2019 |