ICU Medical B9695Recalls & 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-2610-2018 · Jul 31, 2017 · Terminated
  32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic devi
• Z-2613-2018 · Jul 31, 2017 · Terminated
  Lopez Valve w/Red Cap, 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 o
• 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
• 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-2609-2018 · Jul 31, 2017 · Terminated
  168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended
• Z-2608-2018 · Jul 31, 2017 · Terminated
  108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave, Clave, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use,
• 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-2607-2018 · Jul 31, 2017 · Terminated
  185 cm (73") 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 f
• 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-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-2622-2018 · Jul 31, 2017 · Terminated
  84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device i
• 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-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

…and 39 more.