LifeCare PCA infusion system with Hospira MedNet software allows… — Class II medical device recall Z-2141-2016
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-2141-2016 |
|---|---|
| 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 | 38,878 infusion |
| Reason classes | device malfunction |
| 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 and 475 more |
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 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-2141-2016. 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.