Recall Z-0411-2013 ยท ETD Tube, Tympanostomy
Gyrus Acmi, Incorporated
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
| Date | Nov 20, 2012 (initiated Oct 17, 2012) |
| Status | Terminated |
| Reason | One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer. |
| Root cause | Material/Component Contamination |
| Action | 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 retu |
| Quantity | 10 boxes/60 units |
| Distribution | Worldwide distribution: USA state of Kansas and country of Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.