ICU Medical B3232Recalls & 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.

54 other recalls cover devices cleared under the same FDA submission (K983559); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 12, 2026Class IIOpen, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3163-2026 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983559. One submission often covers many models, so check the product and lot details in each record.

• Z-0711-2021 · Aug 31, 2020 · Open, Classified
  26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
• Z-2643-2018 · Jul 31, 2017 · Terminated
  99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogen
• Z-2645-2018 · Jul 31, 2017 · Terminated
  98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave, 2 Gang 4-Way Stopcocks, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single
• Z-2646-2018 · Jul 31, 2017 · Terminated
  132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a
• Z-2634-2018 · Jul 31, 2017 · Terminated
  164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave Clear, Rotating Luer, 1 Ext, Sterile The blood t
• Z-2648-2018 · Jul 31, 2017 · Terminated
  143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave, Luer Lock, Sterile The blood tubing accessory wit
• Z-2619-2018 · Jul 31, 2017 · Terminated
  147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave w/Remv 3 Gang 1o2 Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing a
• Z-2629-2018 · Jul 31, 2017 · Terminated
  132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use
• Z-2616-2018 · Jul 31, 2017 · Terminated
  137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single us
• Z-2617-2018 · Jul 31, 2017 · Terminated
  94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device
• Z-2644-2018 · Jul 31, 2017 · Terminated
  99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non
• Z-2620-2018 · Jul 31, 2017 · Terminated
  135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a sin
• Z-2628-2018 · Jul 31, 2017 · Terminated
  121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 2 Ext, Sterile The blood tubing accessory
• Z-2612-2018 · Jul 31, 2017 · Terminated
  218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave, Check Valve, Y-Connector, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is
• Z-2647-2018 · Jul 31, 2017 · Terminated
  134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Sterile The blood tubing accessory with CLAVE Conn

…and 39 more.