PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

FDA device recall Z-0411-2013 · posted 2012-11-20 · Terminated

Recall details

Recalling firm

Gyrus Acmi, Incorporated

Reason for recall

One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.

Action taken

The firm, Olympus, sent an "URGENT: Medical Device Recall" letter dated October 15, 2012 to their consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to inspect their stock to confirm if any of the affected lot of product remains in their possession; immediately cease any further use of any affected product; remove it from their stockroom and quarantine it until it is shipped back to Gyrus ACMI, Inc.; call their Gyrus ACMI customer service representative (800-773-4301) to obtain a Returned Goods Authorization and promptly return any affected product to Gyrus ACMI, Inc., 2925 Appling Rd, Bartlett, TN 38133., and complete and return the RECALL REPLY FORM to Attn: Regulatory Affairs via fax to: (508) 804-2624, even if there is no affected stock left at your facility. If you have any questions, contact the customer service at 800-773-4301.

Root cause

Material/Component Contamination

Status

Terminated

Product code

ETD

Quantity affected

10 boxes/60 units

Distribution

Worldwide distribution: USA state of Kansas and country of Korea.

Date initiated

2012-10-17

Date posted

2012-11-20

Date terminated

2013-04-09

Location

Southborough, MA