Blood Administration SetRecalls & reported problems across all models

We found 24 models of Blood Administration Set by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 177 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Aug 19, 2025 — classified as 177 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (129 reports).

13 FDA recall records name at least one of these models by its device identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Blood Administration Set recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0620-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0619-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0618-2026 · Root cause: Process control · Recall details · FDA record ↗

4. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0617-2026 · Root cause: Process control · Recall details · FDA record ↗

5. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0616-2026 · Root cause: Process control · Recall details · FDA record ↗

6. Aug 10, 2021Terminated

   Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

   Z-2553-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Nov 20, 2019Terminated

   Potential for leakage at the joint between the blood filters and tubing

   Z-0941-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

8. Nov 20, 2019Terminated

   Potential for leakage at the joint between the blood filters and tubing

   Z-0940-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

9. Nov 20, 2019Terminated

   Potential for leakage at the joint between the blood filters and tubing

   Z-0939-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

10. Nov 20, 2019Terminated

    Potential for leakage at the joint between the blood filters and tubing

    Z-0938-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

11. Nov 20, 2019Terminated

    Potential for leakage at the joint between the blood filters and tubing

    Z-0937-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

12. Nov 20, 2019Terminated

    Potential for leakage at the joint between the blood filters and tubing

    Z-0936-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

13. Nov 20, 2019Terminated

    Potential for leakage at the joint between the blood filters and tubing

    Z-0935-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Blood Administration Set problems

Blood Administration Set models

24 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Blood Administration Set 477005

  Set, administration, intravascular
  2 recalls40 reports
• Blood Administration Set 490530

  Stopcock, i.V. Set
  2 recalls11 reports
• Blood Administration Set 490438

  Set, administration, intravascular
  1 recall37 reports
• Blood Administration Set 490314

  Set, administration, intravascular
  1 recall20 reports
• Blood Administration Set NF5140

  Set, administration, intravascular
  1 recall5 reports
• Blood Administration Set 490293

  Set, administration, intravascular
  1 recall3 reports
• Blood Administration Set V2500

  Set, blood transfusion
  1 recall2 reports
• Blood Administration Set 490196

  Stopcock, i.V. Set
  1 recall1 report
• Blood Administration Set 490355

  Stopcock, i.V. Set
  1 recall1 report
• Blood Administration Set 480233

  Set, administration, intravascular
  1 recall0 reports
• Blood Administration Set 490425

  Set, administration, intravascular
  1 recall0 reports
• Blood Administration Set 354218

  Set, administration, intravascular
  16 reports
• Blood Administration Set 375154

  Set, administration, intravascular
  8 reports
• Blood Administration Set 490321

  Set, administration, intravascular
  8 reports
• Blood Administration Set V2400

  Set, blood transfusion
  7 reports
• Blood Administration Set 477001

  Set, administration, intravascular
  4 reports
• Blood Administration Set NF5145

  Set, administration, intravascular
  3 reports
• Blood Administration Set 490244

  Set, administration, intravascular
  3 reports
• Blood Administration Set 354217

  Set, administration, intravascular
  2 reports
• Blood Administration Set V2511

  Set, administration, intravascular
  2 reports
• Blood Administration Set V2560

  Set, administration, intravascular
  1 report
• Blood Administration Set 470032

  Set, administration, intravascular
  1 report
• Blood Administration Set 490377

  Set, administration, intravascular
  1 report
• Blood Administration Set 490453

  Stopcock, i.V. Set
  1 report

Recent Blood Administration Set adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: IV TUBING BROKE AT VARIOUS PARTS. DETAILED INQUIRY DESCRIPTION: CUSTOMER HAS HAD A SLEW OF IV TUBING THAT BROKE AT VARIOUS PARTS OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842977 ↗
• MalfunctionJul 11, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE SET WAS BEING USED TO ADMINISTER BLOOD TO A PATIENT, IT WAS SET UP IN THE BLOOD WARMER AND WHEN PRIMING THE LINE WITH SALINE IT WAS DISCOVERED THAT THE CONNECTOR WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477940 ↗
• MalfunctionMar 27, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION OF THE PATIENT EVENT: (B)(4) BACKCHECK VALVE BROKE AND DISCONNECTED DURING BLOOD INFUSION. DESCRIBE TYPE OF INTERVENTION: PATIENT DID NOT RECEIVE FULL UNIT OF BLOOD DUE TO DISCONNECTION WAS THERAPY INCOMPLETE, INCORRECT OR INTERRUPTED YES. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985210 ↗
• MalfunctionJun 22, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: BLOOD SET TUBING WAS CRACKED AND LEAKING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14774606 ↗
• MalfunctionMay 5, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION: 4 SETS LEAKING OR BROKEN AT THE BACK CHECK VALVE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285531 ↗
• MalfunctionMay 5, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3: BRIEF INQUIRY DESCRIPTION: 4 SETS LEAKING OR BROKEN AT THE BACK CHECK VALVE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285502 ↗
• MalfunctionMay 5, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION: 4 SETS LEAKING OR BROKEN AT THE BACK CHECK VALVE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285496 ↗
• MalfunctionMay 5, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 4: BRIEF INQUIRY DESCRIPTION: 4 SETS LEAKING OR BROKEN AT THE BACK CHECK VALVE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285429 ↗
• MalfunctionFeb 3, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING LEAKED FROM THE CASSETTE. NO INJURY REPORTED. RESPONSE FROM CUSTOMER; NO BLOOD WAS LOST FOLLOWING EVENT, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13445986 ↗
• MalfunctionDec 27, 2021Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE FILTER BROKE OFF WHILE IN USE. MINIMAL BLOOD LOSS. THE BREAK WAS FOUND WHEN THE PATIENT'S BLOOD PRESSURE CUFF WAS IN USE AND BLOOD BEGAN BACKING UP IN THE TUBING. THE TUBING WAS CLAMPED IMMEDIATELY. NO INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13090733 ↗
• MalfunctionDec 27, 2021Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE FILTER BROKE OFF OF TUBING WHILE RN WAS HYDRATING THE PATIENT WITH IV FLUIDS FOR AN EPIDURAL. ABOUT 100 MLS OF LACTATED RINGERS WAS LOST. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090728 ↗
• MalfunctionDec 15, 2021Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: FLUID LEAKING OUT OF DISC PIECE; DISC PIECE SNAPPED OFF. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010202 ↗
• MalfunctionNov 17, 2021Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE HAND PUMP LEAKED WHEN FORCE WAS APPLIED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832719 ↗
• MalfunctionNov 17, 2021Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE HAND PUMP LEAKED WHEN FORCE WAS APPLIED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832716 ↗
• MalfunctionNov 17, 2021Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT MULTIPLE BLOOD SETS HAVE BEEN CRACKED BETWEEN THE BACKCHECK VALVE AND THE UPPER Y-SITE RESULTING IN LEAKAGE AS THE PREOP NURSES REMOVE THEM FROM THE POUCH. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832691 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Caresite23 models · 420 reports · 4 recalls