FDA Device recall Z-1196-2014
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of Gyrus ACMI Disposable Falope-Ring Band Applicator Kits by Gyrus Medical, citing due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1196-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-19 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Gyrus Medical |
| Distribution | n/a |
Product
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
Reason
Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.
Identifiers
| code_info | Lots: MK761655, MK764022, MK767655, MK526401 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1196-2014%22
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