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U.S. Department of Health and Human Services

Class 2 Device Recall Milex Gellhorn/Flexible ShortStem Pessary with & without kit

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  Class 2 Device Recall Milex Gellhorn/Flexible ShortStem Pessary with & without kit see related information
Date Initiated by Firm January 21, 2021
Date Posted February 26, 2021
Recall Status1 Terminated 3 on January 03, 2024
Recall Number Z-1152-2021
Recall Event ID 87228
510(K)Number K904774  
Product Classification Pessary, vaginal - Product Code HHW
Product Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)
Code Information Recall letter dated 1/21/2021: 1) With Kit: REF #: MXKPGSS2-1/4, Lot #: 276529- Exp Date June 10, 2025, 2) Without Kit: REF #: MXPGSS2-1/4, Lot #: 283083- Exp Date May 12, 2025; Lot 288491- Exp Date May 14, 2025; Lot # 288492- Exp Date May 29, 2025. Recall letter dated 9/8/2021 included one additional lot: 3) REF # MXPGSS2-3/4, Lot 276637- Exp Date February 12, 2026
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 affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions.
FDA Determined
Cause 2		 Process change control
Action On 01/21/2021, CooperSurgical issued Urgent Medical Device Recall notices to customers via certified mail. On 9/08/2021, CooperSurgical expanded the recall adding an additional lot and notified customers via courier service. Customers were advised to: - Discontinue use of and isolate all products subject to the recall. - Complete the Acknowledgement and Receipt Form, and return via email to recall@coopersurgical.com or fax to 203-601-9870. - Once the Acknowledgement Form is received, Cooper Surgical will arrange for Product replacement(s) and return of affected Product(s). The replacement Product(s) will be charged at the same price as the original order and your account will be credited back once the affected Product(s) are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same Form to indicate that and return it to CooperSurgical. Customers with questions, please call 203-601-5200 ext. 3300.
Quantity in Commerce 109 units (Domestic: 60 units, Foreign: 49 units)
Distribution Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, FL, IL, KS, MA, MI, NC, NY, PA, TN, TX, WA, & Puerto Rico. The countries of New Zealand, United Kingdom.
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 = HHW and Original Applicant = MILEX PRODUCTS, INC.
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