CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report
*** Product labeled in part recalled by Hospira
Hospira is recalling *** Product labeled in part: 14951-48, distributed nationwide in the US. The recall was initiated on 9 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2059-2016
- FDA event ID
- 66372
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Sep 2013
- FDA classified
- 29 Jun 2016
- Reported
- 6 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Infusion Pumps
Timeline
| 9 Sep 2013 | Recall initiated by company | |
| 29 Jun 2016 | Classified by FDA | +1024 days |
| 6 Jul 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM); PRIMING VOLUME: 69 ML; *** 3) Product labeled in part: 14954-28; LIFESHIELD; LIFECARE 5000 WITH PROXIMAL 0.2 MICRON FILTER-0L, CONVERTIBLE PIN, DUAL CHANNEL, INTEGRAL Y CLAVE, NON-DEHP; NOMINAL LENGTH: 112 IN (284 CM); PRIMING VOLUME: 24 ML; *** 4) Product labeled in part: List No. 19553-12; LifeShield; LATEX-FREE; PLUM EXTENSION SET WITH CLAVE SECONDARY PORT; NOMINAL LENGTH: 28 IN (71 CM); PRIMING VOLUME: 7.1 ML; SET CONTAINS DEHP; *** 5) Product labeled in part: 19556-28; LIFESHIELD; PLUMSET HEMOSET 100 ML BURETTE, DUAL CHANNEL CASSETTE WITH CLAVE, SECURE LOCK, NON-DEHP NOMINAL LENGTH: 98 IN (249 CM); PRIMING VOLUME: 17 ML; *** 6) Product labeled in part: 19557-28; LIFESHIELD; PLUMSET CONVERTIBLE PIN, TWO INTEGRAL CLAVES, CLAVE SECONDARY PORT AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 110 IN (279 CM); PRIMING VOLUME: 21.4 ML; *** 7) Product labeled in part: 19671-28; LIFESHIELD; CONVERTIBLE PP LIFECARE 5000 CASSETTE W/CLAVE MICRODRIP SOLUSET 150 X 60 DPM, CLAVE INJECTION SITE, NON DEHP; NOMINAL LENGTH: 124 IN (315 CM); PRIMING VOLUME: 13 ML; *** 8) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 9) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; USA; *** 10) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 11) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 12) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 13) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; 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.
Where it was distributed
US (Nationwide) Distribution
Questions about this recall
Why was it recalled?
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Which lots are affected?
***** US DISTRIBUTION ***** *** 1) List Number: 14952-04-01; Lot Numbers: 681775H , 711485H , 750515H , 770115H , 782335H , 800765H , 840515H , 880315H , 962345H , 052015H , 061965H , 121605H , 210165H , 231625H , 231835H , 281085H , 281155H ; *** 2) List Number: 14954-04-28; Lot Numbers: 662045H , 712055H , 051935H , 132675H , 151615H , 231375H , 260465H , 260485H ; *** 3) List Number: 19553-04-12; Lot Number: 751145H; *** 4) List Number: 19556-04-28; Lot Numbers: 750295H , 801115H , 900585H , 040145H , 143175H , 210195H , 281095H ; *** 5) List Number: 19557-04-28; Lot Numbers: 962435H , 040155H , 070705H , 071735H , 082165H , 091245H , 091255H , 091365H , 102515H , 200795H , 200945H , 210835H , 241705H , 280465H , 280475H , 240135H ; *** 6) List Number: 19671-04-28; Lot Numbers: 701785H , 730805H , 811605H , 861435H , 880255H ; *** 7) List Number: 19683-04-28; Lot Numbers: 782315H , 042125H , 211065H , 231825H ; *** 8) List Number: 19685-04-28; Lot Numbers: 682285H , 791285H , 850175H ; *** 9) List Number: 19720-04-28; Lot Numbers: 962305H , 092585H , 121635H , 180645H , 221715H , 260525H ; *** 10) List Number: 19721-04-28; Lot Numbers: 962315H, 132735H; *** 11) List Number: 19729-04-28; Lot Numbers: 032195H , 082285H , 121645H , 170415H , 200235H ; *** 12) List Number: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***** *** 13) List Number: 14951-04-48; Lot Numbers: 761875H , 761905H , 821525H , 830335H , 870625H , 870635H , 880125H , 051955H , 092565H , 142995H , 211715H , 231355H , 271495H , 281105H ; *** 14) List Number: 14952-04-01; Lot Numbers: 681775H , 711485H , 750515H , 770115H , 782335H , 800765H , 840515H , 880315H , 962345H , 052015H , 061965H , 121605H , 210165H , 231625H , 231835H , 281085H , 281155H ; *** 15) List Number: 14954-04-28; Lot Numbers: 662045H , 712055H , 051935H , 132675H , 151615H , 231375H , 260465H , 260485H ; *** 16) List Number: 19732-04-28; Lot Numbers: 114405H , 143545H , 170385H , 170425H , 170395H , 210225H , 201655H , 260535H , 291595H
Where was it sold?
US (Nationwide) Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 66372This product is part of a recall event; the main page for the event is *** Product labeled in part recalled by Hospira.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | *** Product labeled in part recalled by Hospira | Hospira | Packaging Defects | Nationwide | |
| CLASS II | *** Product labeled in part recalled by Hospira | Hospira | Packaging Defects | Nationwide | |
| CLASS II | *** Product labeled in part: List No. recalled by Hospira | Hospira | Packaging Defects | Nationwide | |
| CLASS II | *** Product labeled in part: List No. recalled by Hospira | Hospira | Packaging Defects | Nationwide |
More recalls from Hospira
All 225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Infusion Pumps recalls
All 549| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl | BD Switzerland Sarl | Other | Nationwide |
| Device | CLASS II | IV Non-Dedicated Gravity Administration Sets with drip chambers recalled | ICU Medical | Foreign Material | Nationwide |
| Device | CLASS II | Plum administration sets recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |