Reported Jul 6, 2016 · Terminated

*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port,…

Hospira Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579

Is this the product you have?

3 of 3 products

Products covered by this recall
#Product as published
1Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; ***
2Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; ***
3Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
Lot codes and dates

32 of 32 products

Products covered by this recall
#Product as published
1List Number: 14212-04-28; Lot Numbers: 962235H , 030565H , 030575H , 081425H , 090515H , 100905H , 100915H , 102255H , 102265H , 122515H , 122525H , 143405H , 152655H , 152665H , 152675H , 161375H , 161385H , 161395H , 170955H , 172025H , 172035H , 172045H , 143415H , 241805H , 251735H , 251745H , 250845H ; ***
2List Number: 14254-08-28; Lot Number: 072055H; ***
3List Number: 14687-04-28; Lot Numbers: 650935H , 710435H , 720925H , 721925H , 721895H , 721325H , 721905H , 730175H , 761965H , 771895H , 772175H , 780725H , 781395H , 780715H , 800135H , 800145H , 810185H , 851685H , 840795H , 861775H , 861785H , 810155H , 880695H , 901065H , 901055H , 901095H , 921945H , 020765H , 020775H , 020785H , 020795H , 030185H , 030195H , 042005H , 052335H , 052755H , 052345H , 061035H , 070625H , 080325H , 080335H , 091085H , 092935H , 132125H , 142805H , 153285H , 153495H , 171435H , 180405H , 211275H , 201225H , 201235H ; ***** FOREIGN DISTRIBUTION ***** ***
4List Number: 12193-83-24; Lot Numbers: 662095H , 712345H , 741615H , 880705H , 890735H , 920595H , 952665H , 020485H ; ***
5List Number: 12193-92-28; Lot Numbers: 063285H , 071115H , 071475H , 133335H , 140205H , 171535H , 180045H , 250515H , 281895H ; ***
6List Number: 19194-83-24; Lot Numbers: 662115H , 702305H , 721795H , 721805H , 732055H , 732035H , 732045H , 732065H ; ***
7List Number: 19194-84-24; Lot Numbers: 881945H, 950975H; ***
8List Number: 12194-92-28; Lot Numbers: 071105H , 140085H , 151445H , 180055H ; ***
9List Number: 12195-83-24; Lot Numbers: 662105H , 712355H , 821545H , 880715H , 890745H , 910745H ; ***
10List Number: 12195-84-24; Lot Numbers: 681645H , 681655H , 702295H , 721695H , 721785H , 741635H , 741355H , 761495H , 771395H , 782265H , 782275H , 791315H , 890755H , 900455H , 940615H , 951325H , 010725H , 011475H , 020895H , 021415H ; ***
11List Number: 12195-92-28; Lot Numbers: 063185H , 063195H , 071125H , 102395H , 102405H , 111705H , 111715H , 113055H , 112865H , 131865H , 133405H , 140115H , 153385H , 162385H , 171445H , 180065H , 180075H , 200855H , 210865H , 201895H , 221315H , 250525H , 260235H , 271645H , 270825H ; ***
12List Number: 12196-83-24; Lot Numbers: 662125H , 702315H , 702325H , 712245H , 712255H ; ***
13List Number: 12196-84-24; Lot Number: 871295H; ***
14List Number: 12196-92-28; Lot Numbers: 071135H , 131835H , 151545H , 211645H , 250505H , 281575H ; ***
15List Number: 14001-07-28; Lot Numbers: 810195H , 810205H , 831395H , 830775H , 890985H , 902085H , 220125H ; ***
16List Number: 14001-82-28; Lot Numbers: 890945H , 932935H , 151585H ; ***
17List Number: 14001-83-28; Lot Numbers: 752235H , 851525H , 871535H , 890765H , 900465H , 910215H , 951335H , 960405H , 010735H , 010755H , 020905H , 032185H , 040965H , 053775H , 061775H ; ***
18List Number: 14001-84-28; Lot Numbers: 752254H , 830785H , 851515H , 890775H , 950355H ; ***
19List Number: 14001-92-28; Lot Numbers: 063255H , 081605H , 081615H , 091115H , 161615H , 162365H , 180395H , 190925H , 220155H , 190935H , 190945H ; ***
20List Number: 14007-82-01; Lot Numbers: 811595H, 160345H; ***
Amount recalled
1) 941,982 units; 2) 1,200 units; 3) 4,449,939 units

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

Why it was recalled

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 6, 2016 · Data as of Sep 19, 6:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.