FDA Device recall Z-1518-2015
The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinici…
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinici… by Hospira, citing the infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1518-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-27 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hospira |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.
Reason
The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Identifiers
| code_info | List Number: 20709; Serial Numbers: 15551001 , 15551002 , 15551003 , 15551004 , 15551005 , 15551007 , 15551009 ,…List Number: 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 , 1555 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1518-2015%22
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