—#87705

Product

Lifeshield, latex-free, Primary I.V. Set, convertible pin, 110 inch with removable 3-port high-flow stopcock manifold, backcheck valve, and 2 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 19348-48.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K030002
Affected lot / code info: Lot number: 581305H.

Why it was recalled

Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

Root cause (FDA determination)

Component design/selection

Action the firm took

Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.

Recalling firm

Firm: Hospira Inc.
Address: 375 N Field Dr, Lake Forest, Illinois 60045-2513

Distribution

Distribution pattern: Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.

Timeline

Recall initiated: 2009-11-24
Posted by FDA: 2010-04-15
Terminated: 2012-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87705. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.