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 |
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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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