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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 25, 2003
Date Posted April 22, 2003
Recall Status1 Terminated 3 on September 09, 2003
Recall Number Z-0754-03
Recall Event ID 25830
Product RJ T&A PACK
Code Information Catalog number 002142-000 Lot numbers 000006010, 000005754
Recalling Firm/
Manufacturer
Windstone Medical, Inc.
1602 4th Ave North
Billings MT 59101
For Additional Information Contact Troy Berquist
406-259-6387
Manufacturer Reason
for Recall
Product has latex free symbol on package, yet contains latex components.
FDA Determined
Cause 2
Other
Action On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.
Quantity in Commerce 20
Distribution The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.

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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