openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 12
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI. Catheter and Sharps Safety Features
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Code information
CA-45854-P1A 13F17F0071
Distribution pattern
US in the states of OH, FL, SC, TX, KY, NJ, MI
device · product 7 of 12
ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Code information
CDA-21242-1A 13F16L0209 13F17F0437
Distribution pattern
US in the states of OH, FL, SC, TX, KY, NJ, MI
device · product 8 of 12
ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Code information
CDA-22123-1A 13F17F0744
Distribution pattern
US in the states of OH, FL, SC, TX, KY, NJ, MI
device · product 9 of 12
ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
These labels are deterministic app interpretations, not FDA categories.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
