Recalls / —
—#87807
Product
LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key slide clamp, backcheck valve, 4 Clave ports, piggyback with Option-Loc, attached extension set, 122 inch, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 19689-01
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K052722
- Affected lot / code info
- List Number: 19689-01, Lot Number: 81-147-5H.
Why it was recalled
There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Hospira Inc.
- Address
- 375 N Field Dr, Lake Forest, Illinois 60045-2513
Distribution
- Distribution pattern
- Minnesota and Utah
Timeline
- Recall initiated
- 2010-01-08
- Posted by FDA
- 2010-02-22
- Terminated
- 2011-07-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #87807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.