Recall Z-1152-2021— CooperSurgical, Inc.
Class II · Terminated
Class II FDA medical device recall by CooperSurgical, Inc., initiated 2021-01-21, terminated 2024-01-03. It names one FDA 510(k) clearance: K904774. 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). Reason: 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..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-21
- Terminated
- 2024-01-03
- Firm location
- Trumbull, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.