FDA Device recall Z-2142-2016
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia 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-2142-2016 |
| 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 Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.
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. 0F782; Serial Numbers: 100 ; 101 ; 102 ; 105 ; 105 ; 106 ; 106 ; 107 ; 108 ; 108 ; 109 ; 111 ; 112…List No. 0F782; Serial Numbers: 100 ; 101 ; 102 ; 105 ; 105 ; 106 ; 106 ; 107 ; 108 ; 108 ; 109 ; 111 ; 112 ; 114 ; 116 ; 117 ; 119 ; 120 ; 121 ; 122 ; 123 ; 124 ; 125 ; 125 ; 126 ; 126 ; 127 ; 127 ; 128 ; 128 ; 129 ; 129 ; 130 ; 130 ; 131 ; 131 ; 132 ; 132 ; 133 ; 133 ; 134 ; 134 ; 135 ; 135 ; 136 ; 136 ; 137 ; 137 ; 138 ; 138 ; 139 ; 140 ; 141 ; 142 ; 142 ; 143 ; 143 ; 144 ; 144 ; 145 ; 146 ; 147 ; 147 ; 148 ; 148 ; 149 ; 150 ; 150 ; 151 ; 152 ; 153 ; 154 ; 154 ; 155 ; 155 ; 156 ; 157 ; 158 ; 158 ; 159 ; 160 ; 161 ; 162 ; 162 ; 163 ; 164 ; 164 ; 165 ; 165 ; 166 ; 166 ; 167 ; 167 ; 168 ; 169 ; 170 ; 171 ; 172 ; 172 ; 173 ; 173 ; 174 ; 174 ; 175 ; 175 ; 176 ; 176 ; 177 ; 177 ; 178 ; 178 ; 179 ; 180 ; 181 ; 182 ; 183 ; 183 ; 184 ; 184 ; 185 ; 186 ; 186 ; 187 ; 188 ; 188 ; 189 ; 189 ; 190 ; 191 ; 192 ; 193 ; 194 ; 195 ; 196 ; 197 ; 198 ; 199 ; 200 ; 20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Hospira
- Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest…
FDA Drug · Class I · 2017-05-31 · Hospira - Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to…
FDA Device · Class II · 2017-01-18 · Hospira - 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured…
FDA Drug · Class III · 2016-12-14 · Hospira - Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093…
FDA Drug · Class II · 2016-11-30 · Hospira - Symbiq Two Channel Infuser
FDA Device · Class II · 2016-11-16 · Hospira
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2142-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.