Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provi
Summary
The FDA issued a Class II for Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigi by Cook Inc.. Reason: Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions m.
Details
Source
Device Recall
External ID
Z-0414-2022
Action Date
2021-12-29
Status
Ongoing
Category
device
Product Description
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
Lot/Code Info: RPN 090010/GPN G14254: LOT NUMBER UDI 13977925 (01)00827002142541(17)240524(10)13977925 14030949 (01)00827002142541(17)240617(10)14030949 14054162 (01)00827002142541(17)240628(10)14054162 14116047 (01)00827002142541(17)240728(10)14116047 RPN 090010-ET/GPN G15290: LOT NUMBER UDI 14038615 (01)00827002152901(17)240618(10)14038615
Quantity Affected: 112 US, 240 OUS
Reason for Recall
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA and the countries of France, Italy, and Mexico.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-13
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 113 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cook Inc. has 7 FDA actions in our database, including 7 recalls.
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 Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Inc. have FDA actions?
Cook Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0414-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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