FDA Medical Device Recalls (openFDA)
Windstone Medical, Inc.: PENROSE ACE BANDAGE
- Recall number
- Z-0771-03
- Recalling firm
- Windstone Medical, Inc.
- Product
- PENROSE ACE BANDAGE
- Status
- Terminated
- Initiated
- 2003-03-25
- Posted
- 2003-04-22
- Terminated
- 2003-09-09
- Reason
- Product contains latex, but not labeled as containing latex.
- 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
- 320
- 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-3294 Lot Numbers 000000819, 000000820, 00001431, 000001432, 000002405, 000002533, 000002755, 000003124, 000003125, 000004077, 000004189, 000004657, 000004658, 000005472, 000005979
- 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