Reported Mar 10, 2021 · Terminated
Milex Gellhorn Flexible under the following labels
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
Milex Gellhorn Flexible under the following labels
3 of 3 products
| Model / number | Product as published |
|---|---|
MXKPGSS2-1/4 | Gellhorn Flexible w/Short Stem Pessary, , 2-1/4" (57 mm) with Kit |
MXPGSS2-1/4 | Gellhorn Flexible w/Short Stem Pessary, , 2-1/4" (57 mm) without Kit |
MXPGSS2-3/4 | Gellhorn Flexible w/Short Stem Pessary, , 2-3/4" (70 mm) |
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published — With Kit: REF #: MXKPGSS2-1/4, Lot #: 276529- Exp Date June 10, 2025 — 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 MXPGSS2-3/4Lot 276637- Exp Date February 12, 2026 - Amount recalled
- 109 units (Domestic: 60 units, Foreign: 49 units)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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