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U.S. Department of Health and Human Services

Class 3 Device Recall OASIS Medical SOFT PLUG

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  Class 3 Device Recall OASIS Medical SOFT PLUG see related information
Date Initiated by Firm July 06, 2006
Date Posted September 23, 2006
Recall Status1 Terminated 3 on September 01, 2011
Recall Number Z-1520-06
Recall Event ID 36277
510(K)Number K013613  
Product Classification Medical plug - Product Code LZU
Product OASIS¿ Medical SOFT PLUG¿ Extended Duration Plug, Reference 6403 (Lot LA1105E)
Code Information Lot LA1105E
Recalling Firm/
Manufacturer		 Oasis Medical Inc
512 S Vermont Ave
Glendora CA 91741-6205
For Additional Information Contact Brett Nelson
626-852-5156
Manufacturer Reason
for Recall		 Labeled with an incorrect diameter
FDA Determined
Cause 2		 Package design/selection
Action OASIS¿ Medical informed all customers via FAX and Certified Mailt that received the product that the firm was voluntarily recalling one lot of the SOFT PLUG¿ Extended Duration Plugs (REF 6403) and to cease use immediately. Customers are advised to check their inventory and return any remaining and return all unused product to OASIS¿ Medical SOFT PLUG¿ Extended Duration Plugs (REF 6403) from Lot LA1105E by FedEx. Customers are also advised that if they have used the product, to inform OASIS Medical of the number of samples of this lot used for an accurate account of the product distributed, used and returned.
Quantity in Commerce 1,212 SOFT PLUG¿ Extended Duration Plug pouches of Lot LA1105E. Each pouch contains 2 plugs.
Distribution Worldwide distribution ----USA and countries of Chile, and United Kingdom.
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 = LZU and Original Applicant = OASIS MEDICAL, INC.
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