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U.S. Department of Health and Human Services

Class 2 Device Recall Gyrus ACMI Disposable FalopeRing Band Applicator Kits

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  Class 2 Device Recall Gyrus ACMI Disposable FalopeRing Band Applicator Kits see related information
Date Initiated by Firm October 21, 2014
Date Posted June 26, 2015
Recall Status1 Terminated 3 on March 03, 2017
Recall Number Z-0419-2015
Recall Event ID 69584
PMA Number P870076 
Product Classification Device, occlusion, tubal, contraceptive - Product Code KNH
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).
Code Information All lots
Recalling Firm/
Manufacturer		 Gyrus Acmi, Incorporated
136 Turnpike Road
Southborough MA 01772-2118
For Additional Information Contact Laura Storms
484-896-5688
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 74,792 units
Distribution Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = KNH and Original Applicant = Gyrus ACMI, Inc.
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