The PCA 3 infusion pump allows clinicians — Class II medical device recall Z-1517-2015
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 number | Z-1517-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-02-27 |
| Classified | 2015-04-23 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2016-11-07 |
| Distributed | AK, 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 US | CA |
| Quantity | 8,214 units |
| Serial numbers | 1292, 12920041, 12920048, 12920052, 12920056, 12920066, 12920069, 12920079, 12920082, 12920101, 12920102, 12920104, 12920105, 12920106, 12920107, 12920117, 12920121, 12920122, 12920152, 12920158, 12920159, 12920160, 12920174, 12920246, 12920248 and 475 more |
Product
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed 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-1517-2015. 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.