Z-1754-2010

Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon...

Name: Z-1754-2010 Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon...
Creator: Continental Medical Labs,Inc
Published: 2010-04-16
License: https://open.fda.gov/license/

Continental Medical Labs,Inc / initiated 2010-04-16 / Terminated

FDA source

Continental Medical Labs,Inc began a recall of Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL... on 2010-04-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1754-2010
Status: Terminated
Initiated: 2010-04-16
Posted: 2010-06-03
Terminated: 2012-04-05
Recalling firm: Continental Medical Labs,Inc
Product: 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.
Product code: CAH Filter, Bacterial, Breathing-Circuit
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.
FDA root cause: Release of Material/Component prior to receiving test results
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.
Quantity in commerce: 5520
Distribution: Nationwide distribution: WI
Product codes and lots: Lot #'s for RAF Medical, Inc.: 1002092, 1001211, 1002011, 1002192, 1003081, 1003231, 1002012, 1003085, 1001263, 1003186,1004051, 1002112, 1003086, 1003082, 1003245, 1003291, 1002081, 1002111, 1001222, 1002193, 1003083, 1003241, 1002013, 1003084, 1003242, 1001181, 1003296, Lot #'s for Medico-Mart: 10020414, 1002191, 1003088

Product code CAH

K063526Class IIA-M Systems Viromax Viral and Bacterial FilterA-M Systems, Inc. / cleared 2007-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)