FDA Medical Device Recalls (openFDA)
Windstone Medical, Inc.: CLOWARD PACK
- Recall number
- Z-0758-03
- Recalling firm
- Windstone Medical, Inc.
- Product
- CLOWARD PACK
- Status
- Terminated
- Initiated
- 2003-03-25
- Posted
- 2003-04-22
- Terminated
- 2003-09-09
- Reason
- Product has latex free symbol on package, yet contains latex components.
- Root cause
- Other
- 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.
- Quantity
- 258
- Distribution
- The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
- Lot, serial or model codes
- Catalog number CPA-2374 Lot numbers 007253692, 000000329, 000000644, 000001197, 000001988, 000002422, 000002854, 000003293, 000003400, 000004000, 000004498, 000004845, 000005665, 000005763, 000005783, 000006309, 000006530, 000006766
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1000125955
- Firm city
- Billings
- Firm state
- MT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28