—#98897

Product

Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 99 Inch with Drip Chamber Pump, 210 Micron Filter, Prepierced Injection Site and Secure Lock; a sterile Rx tubing set for the alternate administration of fluids from a blood bag and I.V. solution container; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA; List No. 12698-65 For the alternate administration of fluids from a blood bag and I.V. solution container

FDA product code: KDC — Instrument, Surgical, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K780880
Affected lot / code info: List No. 12698-65, lot 942905H

Why it was recalled

There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.

Root cause (FDA determination)

Other

Action the firm took

The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated March 28, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return the Reply Form via fax to 1-866-324-3734, even if you do not have the affected product; inform healthcare professionals in their organization of this recall; if they have distributed the product further, notify their accounts and have them fax the reply form to 1-866-324-3724; return the affected product to Stericycle using labels provided, and call Stericycle at 1-877-877-0481, if they have not received a return label. For medical inquiries, please call Hospira Medical Communications at 1-800-615-0187. Call Hospira Global Product Safety and Complaints at 1-800-441-4100 (8am-5pm CST, M-F) or by e-mail at (ProductComplaintsPP@hospira.com).

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore.

Timeline

Recall initiated: 2011-03-28
Posted by FDA: 2011-04-19
Terminated: 2012-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98897. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.