Recall Z-2025-2011
Hospira Inc. · initiated March 28, 2011
Product
Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 100 Inch with Clave 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. 12450-48 For the alternate administration of fluids from a blood bag and I.V. solution container
Codes / lots: List No. 12450-48, lots 930875H and 940445H
Reason for recall
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.
FDA-determined cause: Other
Action taken
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).
Details
- Recall number
- Z-2025-2011
- Initiated
- March 28, 2011
- Posted by FDA
- April 19, 2011
- Terminated
- May 9, 2012
- Product code
- KDC – Instrument, Surgical, Disposable
- Quantity
- 47,472 sets
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore.
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2024-2011 | Hospira Latex-Free Blood Secondary Set, 26 Inch with Secure Lock; a sterile Rx tubing…There is a potential for the air filter at the distal end of the set to become detached. This could result… | 03/28/2011Terminated |
| Z-2026-2011 | Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 99 Inch with Drip…There is a potential for the air filter at the distal end of the set to become detached. This could result… | 03/28/2011Terminated |
| Z-2027-2011 | Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110…There is a potential for the air filter at the distal end of the set to become detached. This could result… | 03/28/2011Terminated |