Z-2874-2016Class II

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

Name: Z-2874-2016 LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of...
Creator: Hospira Inc.
Published: 2013-03-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-03-08 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications on 2013-03-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2874-2016
Classification: Class II
Status: Terminated
Initiated: 2013-03-08
Posted: 2016-09-22
Terminated: 2016-11-07
Recalling firm: Abbott Medical
Product: LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
Product code: MEA Pump, Infusion, Pca
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Hospira will contract with Stericycle, Inc. in Indianapolis, IN to send letter and a reply form to Hospira, Inc. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating the number of pumps on hand and that they have received the letter and notified their users. In addition, letters will be sent by email to ECRI, NRAC, Noblis and ISMP for notification of their members and posting on their websites. The letter will also be posted to the Hospira website. Letters will be sent to Hospira customers of record who purchased the devices directly from Hospira. Customers will be directed to notify their consignees if they further distributed the product and confirm they have done so. Telephone attempts will be made to contact customers that do not respond in order to confirm receipt of the letter. Final effectiveness will be done as the devices are upgraded with new plastic motors.
Quantity in commerce: 69
Distribution: United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2874-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2873-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-22
Z-2874-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-22

Product code MEA

K042800Class IILifecare Pca Infusion System with Hospira Mednet SoftwareHospira, Inc. / cleared 2004-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)