FDA Recall
Terminated
Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. MAJOR PACK
Recall: Z-0753-03
·
Initiated March 25, 2003
Recall
- Recall Number
- Z-0753-03
- 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
Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. MAJOR PACK
Reason
Product has latex free symbol on package, yet contains latex components.
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.
Quantity
8