Device recall: LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician…

Class II FDA enforcement event 64230. Recall start date: 8 Mar 2013. Status in the FDA record: Terminated. Termination date: 7 Nov 2016.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Hospira Inc. started this device recall on 8 Mar 2013. The firm address in the FDA record is in Lake Forest, IL. FDA put the recall in Class II. FDA event 64230 has 2 product records. The first FDA enforcement report date is 28 Sep 2016. The record gives the status Terminated, with the termination date 7 Nov 2016.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

Hospira Inc., Lake Forest, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 64230: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2873-2016	LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.	8,794	Class II	Terminated	28 Sep 2016
Z-2874-2016	LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.	69	Class II	Terminated	28 Sep 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 151

Other events of the firm

Other FDA enforcement events of Hospira Inc.
Initiated	Product (first record)	Type	Class	Records
21 Apr 2017	Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospir	Drug	Class I	1
1 Nov 2016	Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 6	Drug	Class II	1
15 Aug 2016	DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx	Drug	Class II	1
29 Jun 2016	5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia	Drug	Class III	1
23 Jun 2016	Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32	Drug	Class II	1
6 May 2016	Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01	Drug	Class II	1
25 Mar 2016	The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enter	Device	Class II	2
23 Mar 2016	Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vial	Drug	Class III	1
23 Mar 2016	Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vial	Drug	Class I	1
18 Mar 2016	8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest,	Drug	Class I	1

Hospira Inc.: all 151 events

Official channels

FDA enforcement report Z-2873-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 64230. https://recallregister.com/fda/ii/64230/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
What quantity of product is in FDA event 64230?: The event has 2 product records. The first record gives this quantity: 8,794
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.