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
Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Code information
Material number: ASK-04018-CC, ASK-04510-HUM, ASK-04550-UHC, Device Listing D025180
Distribution pattern
Worldwide Distribution - US (nationwide) and Canada
device · product 2 of 12
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Code information
Material number: Ask-04301-WBH Device Listing D040650
Distribution pattern
Worldwide Distribution - US (nationwide) and Canada
device · product 3 of 12
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Code information
Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883
Distribution pattern
Worldwide Distribution - US (nationwide) and Canada
device · product 4 of 12
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue Plus (R) Catheter and Sharps Safety Features 4) Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue Flex Tip(R)ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features 5)Pressure Injectable ARROWg+ard Blue Plus (R) Multi-Lumen Central Venous Catheterization Kit 6)AGB+Multi-Lumen Central Venous Catheterization Kit 7) AGB+Pressure Injectable Multi-Lumen CVC Kit The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access. Catheter, Intravascular, Therapeutic, Short Term Less Than 30 days
Worldwide Distribution - US (nationwide) and Canada
device · product 5 of 12
1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Code information
Material number: ASK-45552-RWJ4 Device Listing D213817
Distribution pattern
Worldwide Distribution - US (nationwide) and Canada
device · product 6 of 12
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use. Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Worldwide Distribution - US (nationwide) and Canada
device · product 7 of 12
1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Code information
Material number: CDA-21242-1A, CDA-29803-1A, CDC-21242-1A, CDC-29803-1A, CDC-29903-1A Device Listing D025768
Distribution pattern
Worldwide Distribution - US (nationwide) and Canada
device · product 8 of 12
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavia, or femoral veins Catheter, hemodialysis non-implanted
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Code information
Material number: CDA-22122-U1A, CDC-22141-1A CDC-26142-1A Device Listing D025726
Distribution pattern
Worldwide Distribution - US (nationwide) and Canada
device · product 9 of 12
Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation
27,485 units distributed in U.S., 4,371 units distributed internationally
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
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 components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
These labels are deterministic app interpretations, not FDA categories.
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 components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
Code information
Material number: CDC-12703-1A, CDC-12802-1A, CDC-15703-1A, CDC-15703-B1A, CDC-15802-1A, Device Listing E426708
Distribution pattern
Worldwide Distribution - US (nationwide) and Canada
device · product 11 of 12
ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
27,485 units distributed in U.S., 4,371 units distributed internationally
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
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 components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
These labels are deterministic app interpretations, not FDA categories.
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 components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
Code information
Material number: CDC-24301-1A, CDC-24306-1A Device Listing D025398
Distribution pattern
Worldwide Distribution - US (nationwide) and Canada
device · product 12 of 12
Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
27,485 units distributed in U.S., 4,371 units distributed internationally
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
These labels are deterministic app interpretations, not FDA categories.
The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
Code information
Material number: EU-04041-HPMSB, EU-05052-HPMSB, EU-05041-HPMSB Device Listing D000801
Distribution pattern
Worldwide Distribution - US (nationwide) and Canada
