ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended

FDA device recall Z-1170-2009 · posted 2009-04-07 · Terminated

Recall details

Recalling firm

Cardinal Health 303 dba Cardinal Health

Reason for recall

The recall was initiated as a result of a potential for out of specification flow rates. The product may not consistently meet the labeled flow rate range of +/- 15%.

Action taken

Cardinal sent an Urgent: Medical Device Recall Notification letter, dated 12/19/2008, to consignees on December 22, 2008 stating the Public Reason for Recall, and informing them of the Short Term and Long Term Actions. In addition a modification to the "Dear Pharmacist" letter, FAQ and Recall Response Card was mailed beginning January 26, 2009 to clarify that the pharmacist's ReadyMed products should be sent directly to their distributor and the credit for their product will also be provided through their distributor. Cardinal Health will work directly with the distributor and not the pharmacist as they are not Cardinal Health's direct consignee. Short Term: All ReadyMed elastomeric ambulatory infusion system models are subject to this recall. Cardinal Health is requesting that the use of the ReadyMed elastomeric ambulatory infusion system be discontinued and that the product be returned to Cardinal Health for credit. -Immediately complete and return the enclosed pre-addressed and postage paid Recall Response Card. Note on the card the ReadyMed elastomeric ambulatory infusion system models, lot numbers and quantities that will be returned. Cardinal will provide a courier mailing package for that return and will process consignees' credit. -Customers who purchased through a distributor will receive their credit through that distributor and not directly from Cardinal Health. -Consignee distributor has already been notified of this recall. If you have any questions, please contact your distributor directly, or call the Cardinal Health ReadyMed Recall Call Center at the number below. -Enclosed is a Frequently Asked Questions (FAQ) Letter for Pharmacists to address any questions or concerns related to the use of the ReadyMed elastomeric ambulatory infusion system. Long Term Actions: cardinal Health is continuing to investigate the out of specification condition of the ReadyMed elastomeric ambulatory infusion system and reviewing possible corrective measu

Root cause

Process design

Status

Terminated

Product code

FRN

Quantity affected

Approximately 2.6 million units

Distribution

Nationwide Distribution

Date initiated

2008-12-19

Date posted

2009-04-07

Date terminated

2011-09-13

Location

San Diego, CA

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