Z-2874-2016 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-2874-2016 was initiated by Hospira Inc. on Mar 8, 2013 and is designated Class II. 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… The recall status is terminated (terminated Nov 7, 2016). Affected quantity: 69.

Recall Details

Product Type
Devices
Report Date
Sep 28, 2016
Initiation Date
Mar 8, 2013
Termination Date
Nov 7, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
69

Product Description

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

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.

Distribution Pattern

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

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2874-2016
openFDA file date
Oct 27, 2026
Loaded by RegDataLab
Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.