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.
Reported: November 11, 2020 Initiated: October 22, 2020 #Z-0399-2021
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 61 units
- Distribution
- US distribution to AZ, IA, IN, MA, and ND.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cook Inc.. Units affected: 61 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2020. Severity: Critical. Recall number: Z-0399-2021.
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