LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 d
FDA device recall Z-0808-2010 · posted 2010-02-22 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.
- Action taken
- Hospira Medical issued an "Urgent Device Recall" notification dated January 8, 2010 informing consignees of the affected product. The accounts were instructed to examine their inventory and quarantine affected product immediately and arrange for its return. Users were also requested to complete the enclosed reply form and return it to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 47,904 sets
- Distribution
- Minnesota and Utah
- Date initiated
- 2010-01-08
- Date posted
- 2010-02-22
- Date terminated
- 2011-07-20
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K041550) | Abbott Laboratories | 2004-06-30 |