Class 2 Device Recall LifeShield LatexFree HEMA YType Blood PlumSet

• Date Initiated by Firm: September 29, 2005
• Date Posted: November 15, 2005
• Recall Status: Terminated on November 29, 2007
• Recall Number: Z-0135-06
• Recall Event ID: 33659
• 510(K)Number: K865060 K830014 K941214 K920736
• Product Classification: Set, Blood Transfusion - Product Code BRZ
• Product: LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Inline Dual Channel Cassette, 2 Clave Ports and Option-Lok for use with Plum Series Infusers; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12259-02
• Code Information: list 12259-02, lots 220635H, 230555H, 240305H, 240605H, 250875H, 260495H, 270025H, 271085H, 271645H, 280895H
• Recalling Firm/ Manufacturer: Hospira Inc.; 275 N Field Dr; Lake Forest IL 60045-2579
• For Additional Information Contact: Ms. Luann M. Pendy; 224-212-2000
• Manufacturer Reason for Recall: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
• FDA Determined Cause: Other
• Action: Hospira sent product recall letters dated 9/29/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possibility of the inlet and outlet tubing being reversed on the cassette, which would allow the patient''s blood to be drawn up the tubing. The accounts were requested to examine their inventory for the affected lots, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.
• Quantity in Commerce: 432,270 sets
• Distribution: Nationwide, including Puerto Rico, and internationally to Australia, Mexico, Canada, Taiwan and Saudi Arabia.
• 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 = BRZ and Original Applicant = ABBOTT LABORATORIES; 510(K)s with Product Code = BRZ and Original Applicant = ABBOTT MFG., INC.