FDA Device recall Z-2139-2016
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or ep…
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or ep… 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-2139-2016 |
| 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
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units.
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. 1950; Serial Numbers: 5815 ; 10002 ; 10015 ; 10057 ; 10067 ; 10087 ; 10095 ; 10096 ; 10099 ; 10101 ;…List No. 1950; Serial Numbers: 5815 ; 10002 ; 10015 ; 10057 ; 10067 ; 10087 ; 10095 ; 10096 ; 10099 ; 10101 ; 10107 ; 10109 ; 10111 ; 10112 ; 10118 ; 10122 ; 10123 ; 10125 ; 10128 ; 10129 ; 10130 ; 10131 ; 10132 ; 10134 ; 10136 ; 10137 ; 10142 ; 10143 ; 10146 ; 10148 ; 10149 ; 10151 ; 10154 ; 10162 ; 10163 ; 10164 ; 10165 ; 10167 ; 10168 ; 10169 ; 10170 ; 10171 ; 10172 ; 10174 ; 10176 ; 10178 ; 10179 ; 10180 ; 10181 ; 10182 ; 10183 ; 10185 ; 10186 ; 10187 ; 10188 ; 10189 ; 10190 ; 10192 ; 10193 ; 10194 ; 10195 ; 10196 ; 10199 ; 10200 ; 10202 ; 10203 ; 10204 ; 10205 ; 10206 ; 10207 ; 10208 ; 10209 ; 10210 ; 10211 ; 10212 ; 10214 ; 10216 ; 10217 ; 10220 ; 10221 ; 10222 ; 10223 ; 10224 ; 10226 ; 10228 ; 10229 ; 10232 ; 10233 ; 10234 ; 10236 ; 10237 ; 10238 ; 10241 ; 10242 ; 10243 ; 10244 ; 10245 ; 10246 ; 10247 ; 10248 ; 10249 ; 10250 ; 10251 ; 10252 ; 10255 ; 10256 ; 10257 ; 10258 ; |
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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-2139-2016%22
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