| | Class 2 Recall
Alaris |  |
| Date Posted |
August 03, 2007 |
| Recall Number |
Z-1078-2007 |
| Product |
Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013 |
| Code Information |
Lot Number 07036013
|
Recalling Firm/
Manufacturer |
Cardinal Health 303 Inc DBA Alaris Products
10221 Wateridge Cir
San Diego, California 92121-2733 |
| For Additional Information Contact |
Stacy L. Lewis
858-458-7830
|
Reason for
Recall |
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.
|
| 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 sent multiple copies of the Recall Notification; along with a cover letter outlining their responsibilities to complete the Recall plan and notify their customers as requested. |
| Quantity in Commerce |
4,248 sets (59 boxes) |
| Distribution |
Nationwide. |
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