CLASS II Device recall · Reported 28 Sep 2016 · FDA Enforcement Report

LifeCare PCA 3, PCA recalled by Hospira

Hospira is recalling LifeCare PCA 3, PCA, distributed nationwide in the US. The recall was initiated on 8 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number 12921204 12922976 12924008 12925861 12925924 12925998 12928528 12928807 12929016 12929126 12920432 12920820 12920856 12920915 12921404 12921413 12922304 12922976 12925861 12925998 12927215 12929016 12931044 12931141 12931155 12931192 12931244 12931342 12931361 12931413 12931610 12931639 12931649 12931911 12921480 12921487 12923723 12924326 12924350 12924546 12925259 12925447 12926315 12927938 12928075 12928614 12930418 12930709 12930890 12931441 12931760 12931911 12932487 12932717 12920754 12920791 12920897 12921063 12921613 12922062 12923441 12924161 12926859 12927756 12928775 12929346 12929438 12931942 12920112

Quantity recalled69

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-2874-2016
FDA event ID: 64230
Recalling firm: Hospira, Lake Forest, IL
Classification: Class II
Status: Terminated
Recall initiated: 8 Mar 2013
FDA classified: 22 Sep 2016
Reported: 28 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

8 Mar 2013	Recall initiated by company
22 Sep 2016	Classified by FDA	+1294 days
28 Sep 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.

Where it was distributed

United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.

Nationwide Puerto Rico

Questions about this recall

Is LifeCare PCA 3, PCA recalled?

Yes. Hospira recalled LifeCare PCA 3, PCA on 8 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-2874-2016.

Why was it recalled?

Which lots are affected?

Serial Number 12921204 12922976 12924008 12925861 12925924 12925998 12928528 12928807 12929016 12929126 12920432 12920820 12920856 12920915 12921404 12921413 12922304 12922976 12925861 12925998 12927215 12929016 12931044 12931141 12931155 12931192 12931244 12931342 12931361 12931413 12931610 12931639 12931649 12931911 12921480 12921487 12923723 12924326 12924350 12924546 12925259 12925447 12926315 12927938 12928075 12928614 12930418 12930709 12930890 12931441 12931760 12931911 12932487 12932717 12920754 12920791 12920897 12921063 12921613 12922062 12923441 12924161 12926859 12927756 12928775 12929346 12929438 12931942 12920112

Where was it sold?

United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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