Alaris 9601 (UDI 10885403960116)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

35 other recalls cover devices cleared under the same FDA submission (K133532); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 18, 2025Open, Classified

   Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

   Z-1304-2025 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133532. One submission often covers many models, so check the product and lot details in each record.

• Z-1645-2026 · Feb 11, 2026 · Open, Classified
  BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
• Z-0185-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris Syringe Module, REF 8110
• Z-0184-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris PCU REF 8015
• Z-0186-2024 · Sep 15, 2023 · Open, Classified
  Alaris PCA Module 8120
• Z-1544-2021 · Mar 26, 2021 · Open, Classified
  Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
• Z-1651-2021 · Mar 25, 2021 · Open, Classified
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
• Z-1375-2021 · Mar 24, 2021 · Open, Classified
  Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
• Z-1309-2021 · Mar 3, 2021 · Open, Classified
  BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
• Z-1543-2021 · Feb 26, 2021 · Terminated
  Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
• Z-1331-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
• Z-1332-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
• Z-2204-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
• Z-2910-2020 · Aug 4, 2020 · Open, Classified
  PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2,
• Z-2909-2020 · Aug 4, 2020 · Open, Classified
  Alaris System PC Unit Model 8015
• Z-2939-2020 · Aug 4, 2020 · Open, Classified
  BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.

…and 20 more.