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Class 1 Device Recall Micron Bobbin Vent Tube |
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Date Initiated by Firm |
January 08, 2010 |
Date Posted |
March 04, 2010 |
Recall Status1 |
Terminated 3 on July 27, 2010 |
Recall Number |
Z-0797-2010 |
Recall Event ID |
54356 |
510(K)Number |
K820362
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Product Classification |
Tympanostomy Tube - Product Code ETD
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Product |
MICRON¿ ¿ 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. |
Recalling Firm/ Manufacturer |
Gyrus ACMI Corporation 136 Turnpike Rd Southborough MA 01772-2118
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For Additional Information Contact |
Terrence E. Sullivan 508-804-2739
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Manufacturer Reason for Recall |
Units of the product in lot MH136952 may have been shipped without being sterilized.
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FDA Determined Cause 2 |
Pending |
Action |
The 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 Commerce |
19 boxes of 6 units |
Distribution |
Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = ETD and Original Applicant = RICHARD'S MEDICAL EQUIP., INC.
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