FDA Medical Device Recalls (openFDA)
Windstone Medical, Inc.: BAND BAG W/FASTENER
- Recall number
- Z-0768-03
- Recalling firm
- Windstone Medical, Inc.
- Product
- BAND BAG W/FASTENER
- 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
- 1600
- 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-50009 Lot numbers 000000875, 000000876, 000000877, 000000878, 000000879, 000000880, 00000881, 000000882, 000000883, 000000884, 000000885, 000000886, 000000887, 000000888, 000000889, 000000890, 000000891, 000000892, 000000893, 000000894, 000001235, 000001236, 000002011, 000002012, 000003160, 000003161, 000003162, 000005535, 000005939, 000006004
- 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