Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan).

FDA device recall Z-0419-2015 · posted 2015-06-26 · Terminated

Recall details

Recalling firm

Gyrus Acmi, Incorporated

Reason for recall

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.

Action taken

Olympus sent an Urgent Medical Device Recall letter dated October 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Olympus requires you to take the following action: I. Immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 2. Call your Olympus customer service representative at 1-888-524-7266 to obtain a Returned Goods Authorization so that you may return the product with no charge to you. Olympus will issue a credit t or replacement to your facility y for any returned product. 3. Please note on the enclosed questionnaire that you have received this information. 4. Fax the completed questionnaire to 484-896-7128 regardless of whether you have any affected inventory at your facility. ln addition, if you may have further distributed this product, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter.

Root cause

Process control

Status

Terminated

Product code

KNH

Quantity affected

74,792 units

Distribution

Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe

Date initiated

2014-10-21

Date posted

2015-06-26

Date terminated

2017-03-03

Location

Southborough, MA