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Terminated

Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each.

FDA Recall Z-0720-05 · Posted 2005-04-22

Recalling FirmBard Access Systems, Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2004-11-03
Date Terminated2005-04-22
Product Quantity2360 units

Reason for Recall

Conductivity gel pouches, labeled as sterile, may not be sterile.

Firm Action

All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.

Root Cause

Other

Distribution Pattern

Nationwide. Foreign distribution to: Austria; Bahrain, Belgium, Bermuda, Brazil, Canada, Greece, Hong Kong, Italy, Japan, Kuwait, Malaysia, Mexico, Norway, Oman, Pakistan, Portugal, Qatar, Saudi Arabia, Switzerland, Turkey, United Arab Emirates, United Kingdom.

Official Source

View FDA Recall →

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

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