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Terminated

Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.

FDA Recall Z-1229-2007 · Posted 2007-09-20

Recalling FirmC.R. Bard Access Systems, Inc
Recall StatusTerminated
Product CodeMPB
Date Initiated2007-08-10
Date Terminated2008-04-25
Product Quantity7225 units

Reason for Recall

Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.

Firm Action

Consignees were notified by letter on 08/10/2007 and asked to remove and return all unused affected product to Bard.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Canada, Latin America, and Europe (Austria, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, and Sweden).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K844433VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULAVas-Cath of Canada , Ltd. · 1985-03-13

Official Source

View FDA Recall →

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

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