Data Foundry

Medical device recalls 2015

The LifeCare PCA infusion system with Hospira MedNet software allows… — Class II medical device recall Z-1518-2015

Terminated recall by Hospira Inc., reported 2015-04-29, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn

Recall numberZ-1518-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHospira Inc., Lake Forest, IL, United States
Recall initiated2013-02-27
Classified2015-04-23
Reported by FDA2015-04-29
Terminated2016-11-07
DistributedAK, AL, AR, AZ, CA, CO, CT, DC, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Countries outside the USCA
Quantity38,882
Serial numbers15551001, 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

The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.

Reason for recall

The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.

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-1518-2015. 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.