Recalls / —
—#108703
Product
LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number 12030-12. Product Usage: For administration of I.V. fluids.
- FDA product code
- FRN — Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K865060
- Affected lot / code info
- list number 12030-12; lot number 89-029-5H; expiration date 01 JUN 2013
Why it was recalled
The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention.
Root cause (FDA determination)
Process control
Action the firm took
Hospira, sent an "URGENT DEVICE RECALL" letter dated April 25, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product to return for credit. A Reply Form was enclosed for customers to complete and return via fax to 1-888-386-2073 or e-mail to: Hospira8503@stericycle.com. Contact Hospira Customer Care at 1-877-946-7747 for information regarding product availability.
Recalling firm
- Firm
- Hospira Inc.
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Distribution pattern
- Worldwide Distribution - USA (nationwide) including the states of: Alabama, Colorado, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Oklahoma, Pennsylvania, Wisconsin and the country of Australia.
Timeline
- Recall initiated
- 2012-04-25
- Posted by FDA
- 2012-05-04
- Terminated
- 2016-12-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #108703. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.