Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patient

FDA device recall Z-1673-2014 · posted 2014-05-30 · Terminated

Recall details

Recalling firm

Bayer Corp

Reason for recall

There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.

Action taken

Bayer sent an Urgent Medical Device Recall and Removal Letters dated April 3, 2014, and April 30, 2014, were sent to direct accounts to notify them of the bracket issue and to provide additional instructions for testing and/or returning the brackets. As a critical medical needs site currently using Continuum with a recalled bracket you have two options: 1. Immediately return your Continuum(s) for refund. 2. Take actions to ensure continued safe use of your system associated with the bracket recall. You will still be eligible for a refund when you return the system no later than June 30, 2015. When you are ready to return your Continuum(s), please refer to: Enclosure 2: Disassembly Instructions. Enclosure 3: Continuum Return Form. We sincerely regret the inconvenience and impact of the recalls and subsequent removal of Continuum from the market. Should you have questions regarding the pro-rated refund program, please call 877-229-3767.

Root cause

Component design/selection

Status

Terminated

Product code

FRN

Quantity affected

1347

Distribution

Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.

Date initiated

2014-04-03

Date posted

2014-05-30

Date terminated

2015-04-16

Location

Warrendale, PA

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