LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key slide clamp, backcheck valve, 4 Clave ports, piggyba
FDA device recall Z-0809-2010 · 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
- 1,536 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS (K052722) | Hospira, Inc. | 2005-11-02 |