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U.S. Department of Health and Human Services

Class 2 Device Recall PARPARELLATYPE VENT TUBE, 1.02 MM

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  Class 2 Device Recall PARPARELLATYPE VENT TUBE, 1.02 MM see related information
Date Initiated by Firm October 17, 2012
Date Posted November 20, 2012
Recall Status1 Terminated 3 on April 09, 2013
Recall Number Z-0411-2013
Recall Event ID 63629
Product Classification Tube, tympanostomy - Product Code ETD
Product PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC.,

Tympanostomy tube
Code Information JC470075
Recalling Firm/
Manufacturer		 Gyrus Acmi, Incorporated
136 Turnpike Road
Southborough MA 01772-2118
For Additional Information Contact Terrence E. Sullivan
508-804-2739
Manufacturer Reason
for Recall		 One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 10 boxes/60 units
Distribution Worldwide distribution: USA state of Kansas and country of Korea.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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