Recall Z-1754-2010 ยท CAH Filter, Bacterial, Breathing-Circuit
Continental Medical Labs,Inc
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
| Date | Jun 3, 2010 (initiated Apr 16, 2010) |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 5520 |
| Distribution | Nationwide distribution: WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063526 | A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER A-M Systems, Inc., Jun 29, 2007 |