Baxter 2C7627Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00085412004136), received between Dec 29, 2020 and Nov 19, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Filling Problem” (4 reports).

10 other recalls cover devices cleared under the same FDA submission (K993120); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET WAS LEAKING. A BLOOD BAG WAS SPIKED AND CLAMPED APPROPRIATELY WHEN IT WAS OBSERVED THAT BLOOD BEGAN TO LEAK OUT OF THE CLAMPED AREA AND RAPIDLY FILLED THE LARGE CHAMBER RATHER THAN PROPERLY FLOWING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724401 ↗
• MalfunctionJul 22, 2024No Flow; No Flow

  IT WAS REPORTED THAT A BLOOD RECIPIENT SET WOULD NOT FLOW. DURING A PLATELET TRANSFUSION THE BLOOD PRODUCT ¿WAS NOT PROPERLY DRIPPING AND FLOWING.¿ THE PLASMA HAD TO BE REPRIMED WITH NEW TUBING. THE TRANSFUSION WAS COMPLETED WITHIN THREE HOURS. UPON DUE DILIGENCE THE CUSTOMER CONFIRMED THE FLOW ISSUE WAS USER RELATED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802041 ↗
• MalfunctionJul 22, 2024Filling Problem; Improper or Incorrect Procedure or Method; Filling Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A BLOOD RECIPIENT SET UNDER INFUSED. FOUR HOURS INTO A PATIENT BLOOD TRANSFUSION, ONLY 250 CC OF THE BLOOD WAS INFUSED INTO THE PATIENT. THE TUBING SET WAS PRIMED WITH NORMAL SALINE, LINE WAS FLUSHED ¿SEVERAL TIMES¿, AND BLOOD WAS PLACED ¿HIGH ON THE POLE¿ UPON DUE DILIGENCE THE CUSTOMER CONFIRMED THE FLOW ISSUE WAS USER RELATED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801901 ↗
• MalfunctionJul 22, 2024Filling Problem; Filling Problem

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET DID NOT FLOW ACCURATELY. PRIOR TO THE TRANSFUSION, TO FACILITATE PROPER FLOW OF THE RED BLOOD CELLS (RBC), THE BLOOD TUBING HAD TO BE COMPLETELY RE-PRIMED WITH SALINE. ONCE PRIMING WITH NORMAL SALINE, THE BLOOD FLOWED WITH NO DIFFICULTIES AND THE TRANSFUSION WAS COMPLETED WITHIN THE PROPER TIME FRAME. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793481 ↗
• MalfunctionJul 15, 2024Filling Problem; Filling Problem

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET RECIPIENT SET DID NOT EFFECTIVELY INFUSE DURING A BLOOD TRANSFUSION. THE PATIENT WAS NOT ABLE TO RECEIVE THE FULL BLOOD TRANSFUSION. THIS OCCURRED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746398 ↗
• MalfunctionMar 26, 2021Filling Problem; Filling Problem

  IT WAS REPORTED THAT AN UNDERINFUSION OCCURRED DURING USE OF A Y-TYPE BLOOD/SOLUTION SET. THIS WAS IDENTIFIED DURING PATIENT INFUSION. IT WAS FURTHER REPORTED THAT APPROXIMATELY 1/3 OF THE VOLUME WAS OBSERVED IN BAG OF BLOOD AFTER 3 HOURS OF INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11577426 ↗
• MalfunctionDec 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET LEAKED "ON THE SIDE OF THE Y SECTION." THIS WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11089977 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993120. One submission often covers many models, so check the product and lot details in each record.

• Z-0193-05 · Apr 28, 2004 · Terminated
  Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets that have a luer activated valve for IV access, which allows
• Z-1160-03 · Jul 16, 2003 · Terminated
  Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C6750; Baxter Healthcare Cor
• Z-1162-03 · Jul 16, 2003 · Terminated
  Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 15 drops/mL, 99'', 170 to 260 Micro Filter, Large Standard Blood Filter, 2 Injection Sites, Mal
• Z-1177-03 · Jul 16, 2003 · Terminated
  Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 10 drops/mL, 82'', 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776; Baxter He
• Z-1172-03 · Jul 16, 2003 · Terminated
  Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C
• Z-1175-03 · Jul 16, 2003 · Terminated
  Fenwal Straight Type Blood Set with Large Standard Blood filter, 15 drops/mL, 80'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C6766; Baxter Healthc
• Z-1178-03 · Jul 16, 2003 · Terminated
  Fenwal 3-Lead Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 82'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C7784; Baxter Healt
• Z-1176-03 · Jul 16, 2003 · Terminated
  Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 107'', 2 Injection Sites, Male Luer Lock Adapter, catalog 4C7774; Baxter Healthcare Corporation, Dee
• Z-1161-03 · Jul 16, 2003 · Terminated
  Clearlink System Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8750; Baxte
• Z-1171-03 · Jul 16, 2003 · Terminated
  Baxter Y-Type Blood/Solution Set, 10 drops/mL, 115'', 80 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C7617; Baxter Healthcare Corporation, Deerfield, IL 60015 U