RecallRadar

FDA Device recall Z-2882-2020

BD Alaris System

On 2020-09-16 the FDA classified a Class I recall of BD Alaris System by Carefusion 303, citing the Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2882-2020
ClassificationClass I
Statusongoing
Initiated2020-08-04
Published2020-09-16
Last updated2026-09-13 11:55 UTC
CompanyCarefusion 303
DistributionAK, 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, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY

Product

BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652

Reason

The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.

Identifiers

code_info
Device Model/Serial Number: Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652: All Kits; PCA Module Model 81…Device Model/Serial Number: Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652: All Kits; PCA Module Model 8120: PCA (8120) 14217746 PCA (8120) 14259835 PCA (8120) 13063333 PCA (8120) 14231894 PCA (8120) 14231522 PCA (8120) 14232093 PCA (8120) 14373709 PCA (8120) 12334465 PCA (8120) 13638955 PCA (8120) 13638959 PCA (8120) 14231764 PCA (8120) 14232010 PCA (8120) 14567433 PCA (8120) 14231895 PCA (8120) 14217150 PCA (8120) 14217736 PCA (8120) 14217764 PCA (8120) 14218525 PCA (8120) 14218830 PCA (8120) 14217763 PCA (8120) 13406723 PCA (8120) 13078712 PCA (8120) 13081384 PCA (8120) 13096518 PCA (8120) 13096520 PCA (8120) 13096532 PCA (8120) 13096538 PCA (8120) 13096800 PCA (8120) 13096812 PCA (8120) 13096814 PCA (8120) 13096944 PCA (8120) 13097130 PCA (8120) 13097157 PCA (8120) 13113383 PCA (8120) 13113468 PCA (8120) 13134042 PCA (8120) 13134073 PCA (8120) 13134172 PCA (8120) 13134186 PCA (8120) 13134230 PCA (8120) 13134323 PCA (8120) 14015426 PCA (8120) 14015566 PCA (8120) 14219

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2882-2020%22

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