Z-0135-2008

THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange...

Name: Z-0135-2008 THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange...
Creator: Cook, Inc.
Published: 2007-08-15
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2007-08-15 / Terminated / root cause: manufacturing process

FDA source

Cook, Inc. began a recall of THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm... on 2007-08-15. The reason FDA records is "The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks the manufacturer's...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0135-2008
Status: Terminated
Initiated: 2007-08-15
Posted: 2008-02-06
Terminated: 2008-04-21
Recalling firm: Cook Incorporated
Product: THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 47402 - not on label)
Product code: DQX Wire, Guide, Catheter
Reason for recall: The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks the manufacturer's name and address.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cook Incorporated notified consignees by Urgent Product Recall letter dated 8/15/07 instructing them to return the product.
Quantity in commerce: 33
Distribution: Worldwide Distribution - USA, Australia, India, Trinidad and Tobago.
Product codes and lots: Lot E2026214.

Product code DQX

K832178Class IIAmplatz Heparin Coated CatheterCook, Inc. / cleared 1983-08-12

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)