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U.S. Department of Health and Human Services

Class 2 Device Recall Armstrong Grommet

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  Class 2 Device Recall Armstrong Grommet see related information
Date Initiated by Firm May 12, 2014
Date Posted June 09, 2014
Recall Status1 Terminated 3 on June 19, 2014
Recall Number Z-1731-2014
Recall Event ID 68267
510(K)Number K830228  
Product Classification Tube, tympanostomy - Product Code ETD
Product Armstrong Grommet with wire Otological Ventilation Tube
Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only.

Intended to provide ventilation to the middle ear space through the tympanic membrane.
Code Information Lot #: 147809
Recalling Firm/
Manufacturer		 Summit Medical, Inc.
815 Northwest Pkwy Ste 100
Eagan MN 55121-1658
For Additional Information Contact Nicole Dove
651-789-3921
Manufacturer Reason
for Recall		 One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.
FDA Determined
Cause 2		 Employee error
Action Consignees was sent a Summit Medical "Medical Device Recall" letter, dated May 9, 2014. The letter described the problem and the product involved in the recall. Requested consignees to examine their inventory and to quarantine the product. Consignees need to immediately examine their inventory quarantine any affected product. Also, they are to complete and return the "Recall Response Form." For questions they can contact Nicole Dove at (651) 789-3921 or ndove@summitmedicalusa.com.
Quantity in Commerce 9 boxes
Distribution Worldwide Distribution -- USA, including CA, and GERMANY.
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.
510(K) Database 510(K)s with Product Code = ETD and Original Applicant = MICROMEDICS, INC.
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