Gyrus ACMI Disposable Falope-Ring Band Applicator Kits recall: Contamination
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.…
Why was Gyrus ACMI Disposable Falope-Ring Band Applicator Kits recalled?
All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots
- 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.…
- Recalling firm
- Gyrus Acmi, Incorporated
- Quantity
- 74,792 units
- Distribution
- Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe
- Recall date
- December 3, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)