The LifeCare Pump Model 4200 PCA Infuser makes possible the practical… — Class II medical device recall Z-2142-2016
Terminated recall by Hospira Inc., reported 2016-07-20, distributed nationwide. Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious
| Recall number | Z-2142-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-03-08 |
| Classified | 2016-07-08 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2016-11-07 |
| Distributed | Nationwide (US) |
| Quantity | 6,268 infusion |
| Reason classes | device malfunction |
| Serial numbers | 100, 1000, 10000, 10001, 10002, 10003, 10004, 10005, 10006, 10007, 10008, 10009, 1001, 10010, 10011, 10012, 10013, 10014, 10015, 10016, 10017, 10018, 10019, 1002, 10020 and 475 more |
| Model numbers | 4200PCA |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2142-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.