Atlas FDA

ARTHROSCOPY PACK

FDA device recall Z-0757-03 · posted 2003-04-22 · Terminated

Recall details

Recalling firm
Windstone Medical, Inc.
Reason for recall
Product has latex free symbol on package, yet contains latex components.
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
Quantity affected
4
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

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.