Site-Rite Sterile Needle Guide Kit - 20 gauge
FDA Recall Z-0715-05 · Posted 2005-04-22
Recalling FirmBard Access Systems, Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2004-11-03
Date Terminated2005-04-22
Product Quantity34,619 units
Reason for Recall
Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits 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.