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
This recall has been terminated (originally issued April 22, 2003).
- Company
- Windstone Medical, Inc.
- Recall Initiated
- March 25, 2003
- Posted
- April 22, 2003
- Terminated
- September 9, 2003
- Recall Number
- Z-0753-03
- Quantity
- 8
- Firm Location
- North Billings, MT
- Official Source
- View on FDA website ↗
Reason for Recall
Product has latex free symbol on package, yet contains latex components.
Distribution
The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
Lot / Code Info
Catalog number 002117-000 Lot numbers 000006595, 000006895
Root Cause
Other
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.
More recalls by Windstone Medical, Inc.
SHOULDER PACK
Apr 22, 2003
KNEE PACK
Apr 22, 2003
RJ T&A PACK
Apr 22, 2003
BACK PACK
Apr 22, 2003
Z-0774-03
Apr 22, 2003