Cook recalls Skinny Needle with Chiba Tip (RPN 090010, GPN G14254) due to potential black debris causing local inflammatory reactions. Affected units may need replacement.
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.
Cook is recalling Skinny Needle with Chiba Tip devices that may have black debris inside or on the surface. Using these products could cause inflammation at the site of use. Consumers should check the lot numbers listed in the recall notice.
Black debris inside the device may cause inflammation when used. This debris can be present on the inner stylet or the interior of the outer cannula. Inflammation is a minor reaction that typically resolves without serious complications.
Users of the Skinny Needle with Chiba Tip device who purchased it between specific dates and lot numbers are affected. Patients undergoing procedures requiring this device are most at risk.
Check the product's lot number on the packaging or device. The affected units have specific lot numbers listed in the recall notice: RPN 090010/GPN G14254 with lot numbers starting with UDI 13977925 and RPN 090010-ET/GPN G15290 with lot number UDI 14038615.
Look for the lot number on the device or packaging to determine if it is affected. Affected units have specific lot numbers listed in the recall notice.
Black debris inside the device may cause local inflammatory reactions when used.
Check the lot number on the device or packaging. Affected units have specific lot numbers listed in the recall notice: RPN 090010/GPN G14254 with lot numbers starting with UDI 13977925 and RPN 090010-ET/GPN G15290 with lot number UDI 14038615.
The recall does not specify a remedy, so contact Cook directly for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0414-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-0414-2022 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
