GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 1

FDA device recall Z-1439-2013 · posted 2013-05-31 · Terminated

Recall details

Recalling firm

Gyrus Acmi, Incorporated

Reason for recall

lack of sterility assurance

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.

Root cause

Employee error

Status

Terminated

Product code

LRC

Quantity affected

100 boxes of 6 units

Distribution

Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.

Date initiated

2013-05-24

Date posted

2013-05-31

Date terminated

2014-05-30

Location

Southborough, MA