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

FDA device recall Z-1754-2010 · posted 2010-06-03 · Terminated

Recall details

Recalling firm

Continental Medical Labs,Inc

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.

Action taken

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: rthompson@a-msystems.com with any questions, comments or concerns.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

CAH

Quantity affected

5520

Distribution

Nationwide distribution: WI

Date initiated

2010-04-16

Date posted

2010-06-03

Date terminated

2012-04-05

Location

Waterford, WI

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