FDA Device recall Z-2141-2016
LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely…
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely… by Hospira, citing hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2141-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-08 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hospira |
| Distribution | US |
Product
LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a wide range of clinical settings that includes but is not limited to the following: medical, laboratory/delivery/post-partum, burn unit, surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), pediatrics.
Reason
Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
Identifiers
| code_info | List No. 20709; Serial Numbers: 15551001 ; 15551002 ; 15551003 ; 15551004 ; 15551005 ; 15551007 ; 15551009 ; 155…List No. 20709; Serial Numbers: 15551001 ; 15551002 ; 15551003 ; 15551004 ; 15551005 ; 15551007 ; 15551009 ; 15551010 ; 15551011 ; 15551012 ; 15551013 ; 15551014 ; 15551015 ; 15551016 ; 15551017 ; 15551018 ; 15551019 ; 15551020 ; 15551021 ; 15551022 ; 15551023 ; 15551024 ; 15551025 ; 15551026 ; 15551028 ; 15551029 ; 15551030 ; 15551031 ; 15551032 ; 15551033 ; 15551034 ; 15551035 ; 15551036 ; 15551037 ; 15551038 ; 15551039 ; 15551040 ; 15551041 ; 15551043 ; 15551044 ; 15551045 ; 15551046 ; 15551047 ; 15551048 ; 15551049 ; 15551050 ; 15551051 ; 15551052 ; 15551053 ; 15551054 ; 15551055 ; 15551056 ; 15551057 ; 15551058 ; 15551059 ; 15551060 ; 15551061 ; 15551062 ; 15551063 ; 15551064 ; 15551065 ; 15551066 ; 15551067 ; 15551068 ; 15551069 ; 15551070 ; 15551071 ; 15551073 ; 15551074 ; 15551075 ; 15551076 ; 15551077 ; 15551078 ; 15551079 ; 15551080 ; 15551081 ; 15551082 ; 15551083 ; 15551084 ; 15551085 ; 15551086 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2141-2016%22
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