Atlas FDA

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FDA device recall Z-0774-03 · posted 2003-04-22 · Terminated

Recall details

Recalling firm
Windstone Medical, Inc.
Reason for recall
Product contains latex, but not labeled as containing latex.
Action taken
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.
Root cause
Other
Status
Terminated
Distribution
The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
Date initiated
2003-03-25
Date posted
2003-04-22
Date terminated
2003-09-09
Location
Billings, MT

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