Z-1152-2021 Class II Terminated
FDA device recall Z-1152-2021 was initiated by CooperSurgical, Inc. on January 21, 2021 and is designated Class II. 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 me… The recall status is terminated (terminated January 3, 2024). Affected quantity: 109 units (Domestic: 60 units, Foreign: 49 units).
Recall Details
- Product Type
- Devices
- Report Date
- March 10, 2021
- Initiation Date
- January 21, 2021
- Termination Date
- January 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109 units (Domestic: 60 units, Foreign: 49 units)
Product Description
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)
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.
Distribution Pattern
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.
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