The LifeCare PCA Plus II infusion pump system is designed for safe — Class II medical device recall Z-2139-2016
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-2139-2016 |
|---|---|
| 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 | 53,151 infusion |
| Reason classes | device malfunction |
| Serial numbers | 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 and 475 more |
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 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-2139-2016. 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.