Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Summary
The FDA issued a Class II for Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-3 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-1841-2022
Action Date
2022-10-05
Status
Ongoing
Category
device
Product Description
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Lot/Code Info: RPC-35-145 G06979 UDI-DI: 00827002069794 Lots/Expiration Date: 14774168 07-06-2025 14810021 23-06-2025 14813491 27-06-2025 14816228 28-06-2025 14835046 11-07-2025 14835049 11-07-2025 14845506 18-07-2025 NS14813489 27-06-2025 NS14813489X 27-06-2025 RPC-35-80 G09534 UDI-DI: 00827002095342 Lots/Expiration Date: 14823405 01-07-2025 14823407 01-07-2025 14823408 01-07-2025
Quantity Affected: 363 US; 244 OUS
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-1841-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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