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: 19734-28, 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

Lot, batch or date codes***** US DISTRIBUTION ***** *** 1) List Number: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***** *** 1) List Number: 19732-04-28; Lot Numbers: 114405H , 143545H , 170385H , 170425H , 170395H , 210225H , 201655H , 260535H , 291595H

Quantity recalled3,920,932 units in total

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-2061-2016
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: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) 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

Nationwide

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: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***** *** 1) 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 66372

Reported	Class	Recall	Company	Reason	Where
6 Jul 2016	CLASS II	*** Product labeled in part recalled by Hospira	Hospira	Packaging Defects	Nationwide
6 Jul 2016	CLASS II	*** Product labeled in part: List No. recalled by Hospira	Hospira	Packaging Defects	Nationwide
6 Jul 2016	CLASS II	*** Product labeled in part recalled by Hospira	Hospira	Packaging Defects	Nationwide
6 Jul 2016	CLASS II	*** Product labeled in part: List No. recalled by Hospira	Hospira	Packaging Defects	Nationwide

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