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U.S. Department of Health and Human Services

Class 1 Device Recall Micron Bobbin Vent Tube

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 Class 1 Device Recall Micron Bobbin Vent Tubesee related information
Date Initiated by FirmJanuary 08, 2010
Date PostedMarch 04, 2010
Recall Status1 Terminated 3 on July 27, 2010
Recall NumberZ-0797-2010
Recall Event ID 54356
510(K)NumberK820362 
Product Classification Tympanostomy Tube - Product Code ETD
ProductMICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear.
Code Information Lot Number: MH136952.
FEI Number 3003790304
Recalling Firm/
Manufacturer		 Gyrus ACMI Corporation
136 Turnpike Rd
Southborough MA 01772-2118
For Additional Information ContactTerrence E. Sullivan
508-804-2739
Manufacturer Reason
for Recall		Units of the product in lot MH136952 may have been shipped without being sterilized.
FDA Determined
Cause 2		Pending
ActionThe firm initiated their recall on 01/04/2010 by telephone or visit to their consignees. A follow-up Urgent: Medical Device Recall correspondence, dated 1/14/2010, was sent on 01/27/2010, return receipt requested, to both the consignees and the implanting surgeons. The follow-up letter identified the affected product and described the issue. Customers are to immediately cease any further use of any affected product and quarantine it. Also, they are to obtain a Return Goods Authorization and return the affected product to the firm. The reply form should be completed and also returned. Questions should be directed to customer service at 1-800-773-4301.
Quantity in Commerce19 boxes of 6 units
DistributionNationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = ETD
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