Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA
Summary
The FDA issued a Class II for Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part by Cook Incorporated. Reason: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the ste.
Details
Source
Device Recall
External ID
Z-1836-2022
Action Date
2022-10-05
Status
Ongoing
Category
device
Product Description
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
Lot/Code Info: TSFNA-35-145 G00701 UDI-DI: 00827002007017 Lots/Expiration Date: 14798674 16-06-2027 TSCFNA-35-145-3 G00561 UDI-DI: 00827002005617 Lots/Expiration Date: 14835600 11-07-2027
Quantity Affected: 42 US
Reason for Recall
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-16
Company
Bloomington, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cook Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Incorporated have FDA actions?
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1836-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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