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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 Recall
PARPARELLATYPE VENT TUBE, 1.02 MM
see related information
Date Posted November 20, 2012
Recall Status1 Terminated 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, Massachusetts 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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