GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-
FDA device recall Z-3025-2011 · posted 2011-08-15 · Terminated
Recall details
- Recalling firm
- GYN Disposables Inc
- Reason for recall
- Lack of sterility assurance.
- Action taken
- GYN Disposables Inc. sent out an "Urgent: Medical Device Recall" letter dated July 29, 2011 to all affected customers The letter includes: product affected, description of problem and asks customers quarantine all affected product. They can contact GYN Disposables to have the product picked up and to receive credit. A Response Form is also included. For questions on this recall call (888) 372-2203, extension 101.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HDC
- Quantity affected
- 3987 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-07-29
- Date posted
- 2011-08-15
- Date terminated
- 2012-10-29
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GYN DISPOSABLES TENACULUM 356T (K073182) | Gyn-Disposables, Inc. | 2007-11-28 |