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U.S. Department of Health and Human Services

Class 2 Device Recall Ear/Ulcer Bulb Syringe

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  Class 2 Device Recall Ear/Ulcer Bulb Syringe see related information
Date Initiated by Firm April 30, 2003
Date Posted May 22, 2003
Recall Status1 Terminated 3 on November 14, 2003
Recall Number Z-0860-03
Recall Event ID 26196
Product Classification Syringe, Ent - Product Code KCP
Product GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE
Code Information Catalog # 4173, Lot number 038594A1.
Recalling Firm/
Manufacturer
Medegen Medical Products, LLC
11060 Irma Drive
Northglenn CO 80233
For Additional Information Contact Janet A. Prieur
303-457-2400 Ext. 128
Manufacturer Reason
for Recall
Finished products were not sterilized.
FDA Determined
Cause 2
Other
Action Medegen has notified all direct accounts by certified mail on 4/30/03.
Distribution Nationwide domestic distribution. Foreign distribution to Canada and Saudia Arabia. No government and military consignees.
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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