Juxta-Lite compression wrap XXL Short 28cm Length with Separate Medium AFW Catalog 23137017

FDA device recall Z-1699-2010 · posted 2010-05-27 · Terminated

Recall details

Recalling firm

Circaid Medical Products Inc

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

MDR

Quantity affected

372 total, all sizes

Distribution

Worldwide distribution: USA, Japan, Canada, Netherlands

Date initiated

2010-04-20

Date posted

2010-05-27

Date terminated

2011-01-06

Location

San Diego, CA