Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems,
FDA device recall Z-1078-2007 · posted 2007-08-03 · Terminated
Recall details
- Recalling firm
- Cardinal Health 303 Inc DBA Alaris Products
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 4,248 sets (59 boxes)
- Distribution
- Nationwide.
- Date initiated
- 2007-06-05
- Date posted
- 2007-08-03
- Date terminated
- 2012-02-10
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053 (K872764) | Y | 1987-11-03 |