Z-1229-2007

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

Name: Z-1229-2007 Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt...
Creator: C.R. Bard Access Systems, Inc
Published: 2007-08-10
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2007-08-10 / Terminated

FDA source

C.R. Bard Access Systems, Inc began a recall of Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116 on 2007-08-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1229-2007
Status: Terminated
Initiated: 2007-08-10
Posted: 2007-09-20
Terminated: 2008-04-25
Recalling firm: Bard Access Systems, Inc.
Product: Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.
Product code: MPB Catheter, Hemodialysis, Non-Implanted
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.
FDA root cause: Other
Action: Consignees were notified by letter on 08/10/2007 and asked to remove and return all unused affected product to Bard.
Quantity in commerce: 7225 units
Distribution: Worldwide, including USA, Canada, Latin America, and Europe (Austria, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, and Sweden).
Product codes and lots: Product Code 5583705, Lot Numbers: 22FMA202, 22IMO531, 22KMO573, 22DN2914, 22FN5232, 22GN5835, 22GN5878, 22HN6574, 22BO6078, 22BO6163, 22FO6086, 22GO6026, 22HO6101, 22IO6111, 22KO6124, 22CP6268, 22EP6831, REPG0035, REPG0643, REPH0954, REPK0058, REPK0729, REPL0298, REQB0030, REQB0224, REQD0200, REQF0429, REQF0736, REQJ0282, REQK0875, RERC0052, RERD0719.

Product code MPB

K844433Class IIVaccess 2000 Single Lumen Subclavian CannulaVas-Cath of Canada , Ltd. / cleared 1985-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)