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.
This recall has been terminated (originally issued May 31, 2013).
- Company
- Gyrus Acmi, Incorporated
- Recall Initiated
- May 24, 2013
- Posted
- May 31, 2013
- Terminated
- May 30, 2014
- Recall Number
- Z-1439-2013
- Quantity
- 100 boxes of 6 units
- Firm Location
- Southborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
lack of sterility assurance
Distribution
Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
Lot / Code Info
JC477666
Root Cause
Employee error
Action Taken
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.