The Recall Desk
HighFDA (Devices)·Z-0414-2022·Announced 2021-12-29

Skinny Needle with Chiba Tip recalled for debris contamination

Cook Inc. is recalling Skinny Needles with Chiba Tip due to black debris on internal components that may cause local inflammatory reactions if the product is used.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving contamination of a surgical needle. Although no illnesses or injuries have been reported, the product presents a credible risk of local inflammatory reactions if used, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling Skinny Needles with Chiba Tip (RPN 090010, 090010-ET; GPN G14254, G15290) used in medical procedures.

Specific lots contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Use of affected products may result in local inflammatory reactions.

The affected products were distributed worldwide, including in the United States across multiple states (AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA), as well as France, Italy, and Mexico. A total of 112 units were distributed in the US and 240 units outside the US.

Healthcare providers and patients should not use affected products and should contact Cook Inc. with questions about their specific lot numbers.

The recalled product

Product
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.
Manufacturer
Cook Inc.
Category
Medical Device — Surgical Needle
Hazard
  • foreign-debris
  • inflammatory-reaction
  • contamination

Distribution

Distributed nationwide across the United States.

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