ICU Medical B9290Recalls & 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-2626-2018 · 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-pyrogeni
• Z-2639-2018 · Jul 31, 2017 · Terminated
  128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave, Removable 2 Gang (Blue, Yellow) 1o2 Manifold, Baseplate, 1 Ext, Rotating Luer, Sterile The blood tubing
• Z-2638-2018 · Jul 31, 2017 · Terminated
  162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory
• Z-2630-2018 · Jul 31, 2017 · Terminated
  175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave, Rotating Luer, 1 Ext, Sterile The blood tubing acc
• Z-2649-2018 · Jul 31, 2017 · Terminated
  159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector
• Z-2658-2018 · Jul 31, 2017 · Terminated
  120" (305 cm) 10 Drop Primary Set w/2 MicroClave, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector
• Z-2656-2018 · Jul 31, 2017 · Terminated
  117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector
• Z-2642-2018 · Jul 31, 2017 · Terminated
  100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a sing
• 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-2623-2018 · Jul 31, 2017 · Terminated
  84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, st
• Z-2637-2018 · Jul 31, 2017 · Terminated
  80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, s
• Z-2655-2018 · Jul 31, 2017 · Terminated
  107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector
• Z-2640-2018 · Jul 31, 2017 · Terminated
  112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, no
• Z-2654-2018 · Jul 31, 2017 · Terminated
  126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is

…and 39 more.