Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G017
Summary
The FDA issued a Class II for Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5- 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-1842-2022
Action Date
2022-10-05
Status
Ongoing
Category
device
Product Description
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
Lot/Code Info: THSCF-35-220-1.5-ROSEN G01623 UDI-DI: 00827002016231 Lots/Expiration Date: 14818344 29-06-2027 14820965 30-06-2027 14849857 20-07-2027 THSCF-35-80-1.5-ROSEN G01774 UDI-DI: 00827002017740 Lots/Expiration Date: 14820960 30-06-2027 14832877 08-07-2027 14847945 19-07-2027 THSCF-35-180-1.5-ROSEN G01264 UDI-DI: 00827002012646 Lots/Expiration Date: 14820961 30-06-2027 14843133 15-07-2027 14847946 19-07-2027 THSCF-35-145-1.5-ROSEN G01261 UDI-DI: 00827002012615 Lots/Expiration Date: 14820962 30-06-2027 14820963 30-06-2027 14820964 30-06-2027 14828587 06-07-2027 14835364 11-07-2027 14835365 11-07-2027 14849859 20-07-2027
Quantity Affected: 5041 US; 298 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-1842-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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