ICU Medical B9698Recalls & 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-2606-2018 · Jul 31, 2017 · Terminated
  119" Blood Set w/200 Micron Filter, Clave, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use a
• Z-2631-2018 · Jul 31, 2017 · Terminated
  140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a sin
• Z-2614-2018 · Jul 31, 2017 · Terminated
  Lopez Valve, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipunc
• 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-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-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-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-2635-2018 · Jul 31, 2017 · Terminated
  105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing acce
• 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-2632-2018 · Jul 31, 2017 · Terminated
  100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use
• Z-2657-2018 · Jul 31, 2017 · Terminated
  116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave, 2 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile
• 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-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-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

…and 39 more.