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Terminated

Juxta-Lite compression wrap Large Short 28cm Length with Separate Medium AFW Catalog 23135017

FDA Recall Z-1697-2010 · Posted 2010-05-27

Recalling FirmCircaid Medical Products Inc
Recall StatusTerminated
Product CodeMDR
Date Initiated2010-04-20
Date Terminated2011-01-06
Product Quantity372 total, all sizes

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

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution: USA, Japan, Canada, Netherlands

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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