Recall Z-0399-2021— Cook Inc.
Class I · Terminated
Class I FDA medical device recall by Cook Inc., initiated 2020-10-22, terminated 2021-09-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Cook Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2020-10-22
- Terminated
- 2021-09-02
- Firm location
- Bloomington, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.