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U.S. Department of Health and Human Services

Class 2 Device Recall MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE

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 Class 2 Recall
MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE
see related information
Date Posted May 31, 2013
Recall Status1 Open
Recall Number Z-1439-2013
Recall Event ID 65255
Product Classification Instrument, Ent Manual Surgical - Product Code LRC
Product GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
Code Information JC477666
Recalling Firm/
Manufacturer
Gyrus Acmi, Incorporated
136 Turnpike Road
Southborough, Massachusetts 01772-2118
For Additional Information Contact Terrence E. Sullivan
508-804-2739
Manufacturer Reason
for Recall
lack of sterility assurance
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Cyrus ACMI notified their direct accounts of the recall by Priority Mail with delivery confirmation on May 24, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and immediately cease any further use of any affected product they may have, remove it from inventory, and quarantine it until they ship it back to the firm. For questions customers were instructed to contact their Olympus customer service representative at 1-800-848-9024 to obtain a Returned Goods Authorization so that they may return the product with no charge to them. Customers were asked to note on the enclosed questionnaire that they have received this information and fax it to 484-896-7128. For questions regarding this recall call 508-804-2739.
Quantity in Commerce 100 boxes of 6 units
Distribution Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
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.
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