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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 Recall
Gyrus ACMI Disposable FalopeRing Band Applicator Kits
see related information
Date Posted March 13, 2014
Recall Status1 Open
Recall Number Z-1196-2014
Recall Event ID 67578
Premarket Approval
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 Lots: MK761655, MK764022, MK767655, MK526401
Recalling Firm/
Manufacturer
Gyrus Medical, Inc
6655 Wedgwood Rd N Ste 160
Osseo, Minnesota 55311-3613
For Additional Information Contact Laura Storms
484-896-5688
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Olympus sent an Urgent Medical Device Recall letter dated February 19, 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 856 units
Distribution US Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = KNH and Applicant = ACMI CORPORATION
PMAs with Product Code = KNH and Applicant = CABOT MEDICAL CORP.
PMAs with Product Code = KNH and Applicant = CIRCON CORP.
PMAs with Product Code = KNH and Applicant = GYRUS ACMI, INC.
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