Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RAF2380, RAF2300, RAF2370, RAF2372, RAF2350, RAF2341, RAF2302, RAF2340 RAF2306, RAF2304, RAF2361), or Medico-Mart, Inc. ("Xenon Curcuit" Model number's 2304, 2306). Xenon Diagnostic Circuit Kit: Used in specific Nuclear Medicine Procedures. ViroMax: For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

FDA Recall Z-1754-2010 · Posted 2010-06-03

Recall StatusTerminated
Product CodeCAH
Date Initiated2010-04-16
Date Terminated2012-04-05
Product Quantity5520

Reason for Recall

CML, Inc. was notified by A-M Systems in a letter dated March 31, 2010 that they were recalling a component of their Xenon Kit (ViroMax viral and bacterial filter) because the filters may have a leak at the seam where the two halves of the filter are bonded together.

Firm Action

The firm, A-M Systems, sent two "URGENT: Notification of Product Recall/Correction" letters one dated March 31, 2010 and the other dated April 7, 2010 to customers. The letters described the product, problem and action to be taken by customers. Also enclosed was a list of the affected products that was sold to the consignee. The customer was instructed to cease further distribution or use of any remaining products from the listed lots, immediately notify any customers who received products from the lots, provide A-M Systems with the number of items distributed and still remaining in their inventory, once the number is provided the customer should destroy or discard any remaining product in their possession from these lot numbers. Please feel free to contact Robert Thompson by phone 360-683-8300 x302 or email: [email protected] with any questions, comments or concerns.

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

Nationwide distribution: WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑