Recall Z-1439-2013
Gyrus Acmi, Incorporated · initiated May 24, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: JC477666
Reason for recall
lack of sterility assurance
FDA-determined 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.
Details
- Recall number
- Z-1439-2013
- Initiated
- May 24, 2013
- Posted by FDA
- May 31, 2013
- Terminated
- May 30, 2014
- Product code
- LRC – Instrument, Ent Manual Surgical
- Quantity
- 100 boxes of 6 units
- Distribution
- Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
- Recalling firm
- Gyrus Acmi, Incorporated, Southborough, MA