Recall Z-1170-2009 ยท FRN Pump, Infusion
Cardinal Health 303 dba Cardinal Health
ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents.
| Date | Apr 7, 2009 (initiated Dec 19, 2008) |
| Status | Terminated |
| Reason | 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%. |
| Root cause | Process design |
| Action | 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 pharmac |
| Quantity | Approximately 2.6 million units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |