Recall Z-1439-2013 ยท LRC Instrument, Ent Manual Surgical
Gyrus Acmi, Incorporated
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.
| Date | May 31, 2013 (initiated May 24, 2013) |
| Status | Terminated |
| Reason | lack of sterility assurance |
| Root cause | Employee error |
| 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 retu |
| Quantity | 100 boxes of 6 units |
| Distribution | Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.