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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield Primary I.V. Set

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  Class 2 Device Recall LifeShield Primary I.V. Set see related information
Date Initiated by Firm November 24, 2009
Date Posted April 15, 2010
Recall Status1 Terminated 3 on January 29, 2012
Recall Number Z-1384-2010
Recall Event ID 54079
510(K)Number K033576  
Product Classification Intravascular Administration Set - Product Code FPA
Product Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, 120 inch, convertible pin, with backcheck valve, 3 CLAVE ports, piggyback with OPTION-LOK, and attached extension set, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; list 20795-48.
Code Information Lot numbers: 570395H, 580285H, and 630185H.
Recalling Firm/
Manufacturer		 Hospira Inc.
375 N Field Dr
Lake Forest IL 60045-2513
For Additional Information Contact Ms. Ileana Quinones
224-212-4892
Manufacturer Reason
for Recall		 Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
FDA Determined
Cause 2		 Component design/selection
Action 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.
Quantity in Commerce 70,320 sets
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = ABBOTT LABORATORIES
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