Hospira 1422028Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10887787002475), received between Jul 29, 2022 and Sep 18, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 reports).

11 other recalls cover devices cleared under the same FDA submission (K141789); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829092 ↗
• MalfunctionMay 14, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A PRIMARY PLUM Y-TYPE BLOOD SET IN WHICH IT WAS REPORTED THAT THERE WAS LEAKAGE FROM THE DRIP CHAMBER. THE ISSUE WAS NOTED DURING INFUSION. THERE WAS NO BLEEDBACK, NO BIOHAZARD, NO USER FACILITY MEDWATCH, AND NO CHEMO. THERE WAS PATIENT INVOLVEMENT, BUT NO DELAY IN CRITICAL THERAPY AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178835 ↗
• MalfunctionDec 18, 2025Contamination; Contamination

  AN EMAIL WAS RECEIVED REGARDING A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH WAS CONTAMINATED WITH DIRT ON ONE SIDE. THE EVENT WAS NOTED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840191 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  LEAKAGE OF AN UNSPECIFIED FLUID/INFUSATE WAS REPORTED AT THE BOTTOM OF THE BURETTE OF A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH DEVICE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752511 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE DRIP CHAMBER OF A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH REPORTEDLY LEAKED UNSPECIFIED FLUID FROM THE BOTTOM OF IT. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408712 ↗
• MalfunctionAug 15, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  EVENT OCCURRED WITH REGARDS TO A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH WHERE IT WAS REPORTED THAT THE BLOOD SET BROKE AT THE ELBOW OF THE CASSETTE DURING A BLOOD TRANSFUSION, CAUSING IT TO LEAK FROM THE PUMP. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816613 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH. IT WAS REPORTED THAT THE NORMAL SALINE LEAKED FROM THE CLAVE OF THE CASSETTE AFTER BLOOD TRANSFUSION. THERE WAS NO BLEEDBACK REPORTED. THERE WAS PATIENT INVOLVEMENT REPORTED, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THERE WAS NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322624 ↗
• MalfunctionJun 2, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED, ON AN UNSPECIFIED DATE IN APRIL, THAT A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT DURING BLOOD INFUSION, THE SPIKE DISCONNECTED FROM THE BLOOD BAG RESULTED IN LEAKAGE. THERE WAS NO PATIENT HARM. CUSTOMER COMPLAINT THAT LIST NO. 14220-01 IS EASIER TO SEPARATE FROM BLOOD BAG AFTER CONNECTION COMPARING TO OTHER BRAND PRODUCTS. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127838 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION 06-MAY-2025 INFORMING THAT THE LOT NUMBER IS 13850990 AND THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096747 ↗
• MalfunctionNov 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH EXPERIENCED LEAKAGE. THE REPORTER STATED, ¿LEAKS FROM DRIP CHAMBER." THE EVENT OCCURRED DURING INFUSION. IT WAS ALSO MENTIONED THAT THERE WAS CONCOMITANT DRUG, NO CONCOMITANT DEVICE, NO BLEED-BACK, NO CHEMO, NO BIO-HAZARD AND UNKNOWN USER FACILITY MED-WATCH. TQUANTITY AFFECTED IS 1 AND IT IS AVAILABLE FOR RETURN FOR EVALUATION. SAMPLE PHOTO WAS PROVIDED SHOWING THE LEAKS FROM THE DRIP CHAMBER. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20764614 ↗
• MalfunctionJul 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH. A CRACK ON THE DEVICE WAS REPORTED THAT LED TO BLOOD LEAKAGE. THERE WAS NO REPORT OF HUMAN HARM ASSOCIATED WITH THIS REPORTED EVENT/COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697106 ↗
• MalfunctionApr 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED, ¿PLUM SET DAMAGE, RESULTED IN LEAKAGE AT INLET TUBING OF CASSETTE.¿ THE QUANTITY AFFECTED IS 1, AND THE SAMPLE IS AVAILABLE FOR RETURN. A SAMPLE PICTURE IS AVAILABLE SHOWING THE PRODUCT INVOLVED WITH A RED CIRCLE MARK INDICATING WHERE THERE IS DAMAGE. THE EVENT WAS NOTED DURING INFUSION, AND THE DRUG NAME WAS UNKNOWN. THERE WAS NO DRUG EXPOSURE TO ANYONE AND NO IMPACT ON THE PATIENT OR HEALTHCARE PROVIDER. THE SET WAS REPLACED, AND THERAPY RESUMED. THERE WAS NO OTHER PHYSICAL DAMAGE NOTED TO THE PRODUCT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177887 ↗
• MalfunctionApr 5, 2024Material Puncture/Hole; Material Puncture/Hole

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH WHERE THE CUSTOMER REPORTED TO HAVE CASES THAT HAVE HOLES IN IT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055927 ↗
• MalfunctionApr 3, 2024Material Puncture/Hole; Material Puncture/Hole

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH WHERE IT WAS REPORTED THAT THE PRODUCT HAD A PIN HOLE IN THE PLASTIC ON TOP. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031764 ↗
• MalfunctionJan 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A BLOOD SET WHERE THERE WAS LEAKAGE REPORTED DURING INFUSION. NO DRUG EXPOSURE TO PATIENT OR HEALTHCARE PROVIDER REPORTED. THE SET WAS REPLACED, AND THERAPY RESUMED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18512038 ↗
• MalfunctionAug 31, 2023Crack; Crack

  IT WAS REPORTED THAT A PRIMARY PLUM Y-TYPE BLOOD SET GENERATED A ¿FILTER CRACK". THERE WAS NO PATIENT HARM REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662368 ↗
• MalfunctionAug 20, 2023Crack; Crack

  THE EVENT INVOLVED A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH. THE REPORTER STATED THAT THE FILTER CRACKED. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17581251 ↗
• MalfunctionJun 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, NON-VENTED, SECURE LOCK, 110 INCH WHERE IT WAS REPORTED THAT THE IV BLOOD TUBING DID NOT PROPERLY SEAL OPENING WHEN SPIKED PACKET RED BLOOD CELL (PRBC) BAG. DUE TO THE TUBING NOT PROPERLY FITTING, BLOOD LEAKED OUT OF THE BAG. NEW IV BLOOD TUBING WAS USED AND PROPER SEAL WAS NOTED. THE EVENT OCCURRED AT THE START OF INFUSION. THERE WAS PATIENT INVOLVED HOWEVER NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208118 ↗
• MalfunctionJul 29, 2022Display or Visual Feedback Problem

  ICU MEDICAL PRIMARY PLUM Y-TYPE BLOOD SET IV TUBING RECEIVED MULTIPLE CASSETTE TEST FAILURE NOTIFICATIONS WHEN INITIATING SET UP ON IV PUMP. MULTIPLE ATTEMPTS MADE ON DIFFERENT PUMPS WITH SAME FAILURE MESSAGE RECEIVED. TOTAL OF FOUR TUBING SETS TRIED WITH SAME FAILURE MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128606 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141789. One submission often covers many models, so check the product and lot details in each record.

• Z-3162-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-2447-2024 · May 7, 2024 · Open, Classified
  Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following de
• Z-2430-2023 · Jul 13, 2023 · Open, Classified
  Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 3001010
• Z-1565-2023 · Mar 22, 2023 · Open, Classified
  Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
• Z-0145-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Mic
• Z-0128-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Mic
• Z-0127-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Line
• Z-3031-2017 · Jun 15, 2017 · Terminated
  Plum 360 Infusion System
• Z-1682-2017 · Dec 30, 2016 · Terminated
  Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
• Z-1832-2016 · Mar 25, 2016 · Terminated
  The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver
• Z-1833-2016 · Mar 25, 2016 · Terminated
  The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With it