Coaxial Interventional Needles Recalled for Potential Sterilization Defects

Plain-English summary

INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling multiple lots of Coaxial Interventional Needles. The recalled product includes various configurations with different gauges and lengths, all intended for use in medical interventional procedures.

The recalled needles are labeled as sterile and sterilized using ethylene oxide (EO). The manufacturer determined that certain manufacturing lots may not have been adequately sterilized, which could result in contamination and pose a patient safety risk during interventional procedures.

The FDA has classified this as a Class II recall. The affected lot numbers span multiple article numbers and were distributed in California. Consumers and healthcare facilities should verify lot numbers against the FDA's complete affected lot list before using any inventory.

Healthcare professionals who have used affected lots should be alerted to take appropriate safety precautions. Anyone with questions should contact INNOVATIVE TOMOGRAPHY PRODUCT GMBH directly or consult the FDA's medical device recall database for additional information.

The recalled product

Product

Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G

Manufacturer

INNOVATIVE TOMOGRAPHY PRODUCT GMBH

Category

Medical Device — Interventional Needle

Hazard

• inadequate-sterilization
• infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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