Z-1693-2010

Juxta-Lite compression wrap Large Short 28cm Length with Separate Small AFW Catalog 23125017

Name: Z-1693-2010 Juxta-Lite compression wrap Large Short 28cm Length with Separate Small AFW Catalog 23125017
Creator: Circaid Medical Products Inc
Published: 2010-04-20
License: https://open.fda.gov/license/

Circaid Medical Products Inc / initiated 2010-04-20 / Terminated / root cause: manufacturing process

FDA source

Circaid Medical Products Inc began a recall of Juxta-Lite compression wrap Large Short 28cm Length with Separate Small AFW Catalog 23125017 on 2010-04-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1693-2010
Status: Terminated
Initiated: 2010-04-20
Posted: 2010-05-27
Terminated: 2011-01-06
Recalling firm: Circaid Medical Products Inc
Product: Juxta-Lite compression wrap Large Short 28cm Length with Separate Small AFW Catalog 23125017
Product code: MDR Binder, Medical, Therapeutic
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 372 total, all sizes
Distribution: Worldwide distribution: USA, Japan, Canada, Netherlands
Product codes and lots: All units sold between 2/1/10 and 4/14/10.

Product code MDR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)