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Recall Observatory FDA recall evidence

Device product

Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.

Z-0399-2021

October 22, 2020

Class I

Product summary

Firm
Cook Inc.
Event
Event 86642
Status
Terminated
Classification
Class I
Quantity
61 units
Official record key
device-enforcement:Z-0399-2021

Official wording

Reason: Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.

Code information: Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931

Distribution pattern: US distribution to AZ, IA, IN, MA, and ND.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign matter