Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 20, 2016
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 (
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 (…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Hospira Inc. recalled LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer… - a moderate-severity action.
LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer… was recalled by Hospira Inc. in July 20, 2016. Reason: Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious…. Check the official notice for the remedy. Verify recall #Z-2141-2016 with the FDA Devices before acting.
The recall
Hospira Inc. issued this moderate-severity FDA Devices recall-Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious….
- Moderate
- severity level
- Class II
- classification
- July 20, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2141-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2141-2016) was formally reported on July 20, 2016, with the manufacturer initiating the action on March 8, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Hospira Inc. is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 38,878 infusion pump systems.
The documented reason for this recall is: 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 do… Distribution data in the federal record shows the product reached: Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
38,878 infusion pump systems
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2141-2016 |
| Date reported | July 20, 2016 |
| Date initiated | March 8, 2013 |
| Recalling firm | Hospira Inc. |
| Firm location | Lake Forest, IL |
| Affected scope | 38,878 infusion pump systems |
| Distribution | Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District o… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2141-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira Inc.. Units affected: 38,878 infusion pump systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2016. Severity: Moderate. Recall number: Z-2141-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2141-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 20, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.