FDA Recall
Terminated
n/a
Recall: Z-0774-03
·
Initiated March 25, 2003
Recall
- Recall Number
- Z-0774-03
- Event Number
- 25830
- Firm
- Windstone Medical, Inc.
- FEI Number
- 1000125955
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 25, 2003
- Posted
- April 22, 2003
- Terminated
- September 9, 2003
- Address
- 1602 4th Ave, North Billings, MT, 59101
Description
n/a
Reason
Product contains latex, but not labeled as containing latex.
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.
Distribution
The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.