Continuum recall letter - Medrad

April XX, 2012
To:
URGENT MEDICAL DEVICE RECALL
RE: MEDRAD ®CONTINUUM PUMP AND TUBING SET RECALL
CATALOGUE NUMBERS: MIK 200A, MIL 200B, 3009135, 3015550,
3015153, 3015155, 3015156, 3015157, 3015158, 3015159 and
3015161
Dear Radiology Administrator,
Bayer HealthCare is recalling all MEDRAD® Continuum MR Infusion System tubing
sets (macrobore and microbore), catalogue numbers MIK 200A, MIL 200B,
3015153, 3015155, 3015156, 3015157, 3015158, 3015159, 3015160 and 3015161.
Bayer is initiating this recall because this tubing exhibits a variation that, when used
in conjunction with any Continuum pump, may result in flow rate accuracy
performance issues.
In addition, we are recalling select Continuum pumps, calibrated using the tubing
associated with this recall. This recall action is being reported to the U.S. Food and
Drug Administration (FDA) and other regulatory bodies, as required.
It is important to note that this recall is not a result of patient injury.
This letter provides instructions for:
Returning Recalled Tubing & Impacted Continuum Pumps
Resetting Maximum Flow Rate on Other Continuum Pumps
1. Returning Continuum Tubing and Impacted Pumps
All Continuum tubing should be returned. In addition, if our records indicate
that you have received Continuum pumps calibrated using tubing associated
with this recall, the serial number for the recalled Continuum pump(s) is listed
below:
Serial number(s): [Customer-specific serial numbers]
Please reference section 2 for additional actions required.
MEDRAD, INC.
100 Global View Drive
Warrendale, PA 15086
U.S.A.
1-800-633-7237
www.ri.bayer.com
You will find your pump
serial numbers listed here if
you have pumps at your
site that have been recalled.

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We ask that you follow these steps:
1. If you have inventory from these lots and/or serial numbers, please contact
customer support at 1-800-633-7237 for a return goods authorization (RGA)
number(s) to return the product to Bayer.
2. Record the RGA number (s), along with the total number of impacted
product being returned on the response sheet attached. Fax the response
to compliance at 412-406-0942.
We are presently testing replacement tubing and expect to begin recalibrating
returned Continuum pumps and distributing replacement tubing in late May.
Recognizing that there are many customers to be served, we will establish a
prioritization plan for providing tubing and pumps once we fully understand when
product will become available for shipment. We will work to fully replenish your
inventories as quickly as possible. Full recalibration and resupply of tubing to all
customers is expected to take up to five months once we have acceptable
tubing to distribute.
2. Continuum Pumps Not Subject to This Recall: Resetting Maximum Flow
Rates
If your Continuum pump is not included in the affected serial numbers, it must
still be recalibrated (reprogrammed). To ensure the best performance
compatibility of the Continuum pumps and tubing, we are reverting back to the
originally validated flow rate range of: 0.1 ml/hr to 500 ml/hr. To prepare your
Continuum pump for future operation once new tubing is available, we have
included with this letter instructions to reprogram the limits on your Continuum
pump(s) to the maximum flow rate of 500 ml/hr.
We ask that you take these steps:

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1. Follow the instructions enclosed for resetting the maximum flow rate of your
Continuum pump(s).
2. Fill out the enclosed response form and fax it to 412-406-0942.
Patient safety is Bayer’s primary concern. We appreciate your immediate attention
and cooperation and sincerely regret any inconvenience. If you have questions,
please contact our customer support team at 1-800-633-7237.
Sincerely,
Tim Anderson
Head of Quality
Radiology & Interventional