FDA Medical Device Recalls (openFDA)
Circaid Medical Products Inc: Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Anklet Catalog 23036117
- Recall number
- Z-1691-2010
- Recalling firm
- Circaid Medical Products Inc
- Product
- Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Anklet Catalog 23036117
- Status
- Terminated
- Initiated
- 2010-04-20
- Posted
- 2010-05-27
- Terminated
- 2011-01-06
- Reason
- Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
- Root cause
- Process control
- Action
- CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided. this listing for product returns.
- Quantity
- 372 total, all sizes
- Distribution
- Worldwide distribution: USA, Japan, Canada, Netherlands
- Lot, serial or model codes
- All units sold between 2/1/10 and 4/14/10.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDR
- Firm FEI
- 2243150
- Firm city
- San Diego
- Firm state
- CA
- 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