SHOULDER PACK
FDA Recall Z-0761-03 · Posted 2003-04-22
Recalling FirmWindstone Medical, Inc.
Recall StatusTerminated
Date Initiated2003-03-25
Date Terminated2003-09-09
Product Quantity18
Reason for Recall
Product has latex free symbol on package, yet contains latex components.
Firm 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.
Root Cause
Other
Distribution Pattern
The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.