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U.S. Department of Health and Human Services

Class 2 Device Recall Milex Cervical Dilator

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  Class 2 Device Recall Milex Cervical Dilator see related information
Date Initiated by Firm April 09, 2020
Create Date May 22, 2020
Recall Status1 Terminated 3 on May 11, 2021
Recall Number Z-2112-2020
Recall Event ID 85544
510(K)Number K183020  
Product Classification Hysteroscope (and accessories) - Product Code HIH
Product CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Code Information Lot # 257589
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer Reason
for Recall		 The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HIH and Original Applicant = CooperSurgical, Inc.
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