Recall Z-1078-2007 ยท FRN Pump, Infusion
Cardinal Health 303 Inc DBA Alaris Products
Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013
| Date | Aug 3, 2007 (initiated Jun 5, 2007) |
| Status | Terminated |
| Reason | The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm. |
| Root cause | Other |
| Action | Recall Notification consists of a phone call and Recall Notification letters to consignees (distributors) as well as direct customers. On June 5, 2007, Cardinal Health began calling customers and distributors to inform them of a recall affecting IV Administration Set, Model C20014, Lot Number 07036013 (Low Sorbing Extension Set). A follow-up Recall Notification Letter was sent on June 11, 2007. The customers and distributors were notified by registered return receipt mail. For direct customers, letters were sent directly to the point of contact at the hospital. For distributors, they were sen |
| Quantity | 4,248 sets (59 boxes) |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872764 | IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053 Y, Nov 3, 1987 |