FDAClass IIMarch 12, 2014

*** 1) List number 126970465 labeled in recall

*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump…

Why was *** 1) List number 126970465 labeled in recalled?

Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

*** 1) List number 126970465; Lot Numbers: 281145H, 180015H, 040115H, 8804085H, 782245H, 680585H; *** 2) List Number 127200465; Lot Numbers: 161475H, 153405H, 031595H; *** 3) List Number 046419701: Lot Numbers: 040945G, 131335G

Product
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump…
Recalling firm
Hospira Inc.
Quantity
*** 1) List Number 126970465: 21,860 units; *** 2) List Number 127200465 : 20,256 units; *** 3) List Number 046419701 : 26,900 units
Distribution
Worldwide Distribution: US (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV and Puerto Rico; and countries of Canada, Espana, France, Ireland, and Slovenia.
Recall date
March 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls