510(k) K071538 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
| Applicant | Arrow International, Inc., Reading PA, US |
| Decision | Substantially Equivalent, Aug 30, 2007 |
| Received | Jun 5, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071538
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH;
CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F;
CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F;
3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH;
3L PI CV Open, Classified |
LRS | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A Open, Classified |
FOZ | None listed |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL
VENOUS CATHETER
REF ASK-42802-PLH
UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140
REF ASK-45703-MGH
UDI code: ( Open, Classified |
FOZ | None listed |
| Oct 5, 2023 | ARROW INTERNATIONAL Inc. Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days Open, Classified |
FOZ | None listed |
| Oct 5, 2023 | ARROW INTERNATIONAL Inc. Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days Open, Classified |
FOZ | None listed |
| Dec 10, 2022 | ARROW INTERNATIONAL Inc. Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer Terminated |
FOZ | None listed |
| Dec 10, 2022 | ARROW INTERNATIONAL Inc. Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703- Terminated |
FOZ | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen
Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677) Open, Classified |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1 Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1 Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1 Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1 Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LD Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-427 Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1 Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1 Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH Terminated |
FOZ | None listed |
| Mar 5, 2018 | Arrow International Inc Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions.
Permits venous access and catheter introduction Terminated |
FOZ | None listed |
| Mar 5, 2018 | Arrow International Inc Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions.
Permits venous acc Terminated |
FOZ | None listed |
| Mar 5, 2018 | Arrow International Inc Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features.
Permits venous access to central circulation. Terminated |
FOZ | None listed |
| Mar 5, 2018 | Arrow International Inc Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions.
Permits venous access to Terminated |
FOZ | None listed |
| Mar 5, 2018 | Arrow International Inc Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features.
Permits venous access to central circulation. Terminated |
FOZ | None listed |
| Mar 5, 2018 | Arrow International Inc Pressure Injectable Multi- Lumen CVC Kit Terminated |
FOZ | None listed |
| Mar 5, 2018 | Arrow International Inc ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit.
Intended to permit venous access to the central circulation. Terminated |
FOZ | None listed |
| Feb 20, 2018 | Arrow International Inc Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018 Terminated |
FOZ | None listed |
| Feb 20, 2018 | Arrow International Inc Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018 Terminated |
FOZ | None listed |
| Feb 20, 2018 | Arrow International Inc Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue
FlexTip Catheter and Sharps Safety Features;
Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018 Terminated |
FOZ | None listed |
| Feb 20, 2018 | Arrow International Inc Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous
Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018 Terminated |
FOZ | None listed |
| Feb 20, 2018 | Arrow International Inc AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018 Terminated |
FOZ | None listed |
| Dec 22, 2017 | Arrow International Inc AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-4285 Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc 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 acce Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc 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 prov Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc 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 v Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc 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 centr Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc 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 centra Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc 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 centr Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc 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 Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc 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 Terminated |
FOZ | None listed |
| May 9, 2017 | Arrow International Inc 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 Terminated |
FOZ | None listed |
| Apr 10, 2017 | Arrow International Inc Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit.
Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard te Terminated |
FOZ | None listed |
| Jul 6, 2016 | Arrow International Inc ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER.
Product Usage:
Indicated to provide short-term (<30 days) central venous access for treatment of diseases or co Terminated |
FOZ | None listed |
| Feb 10, 2015 | Arrow International Inc ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins. Terminated |
FOZ | None listed |
| Jan 22, 2015 | Arrow International Inc Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015:
Product Usage:
Multi-Lumen PI CVC Kit: An intravascular catheter is a device that co Terminated |
FOZ | None listed |
| May 19, 2014 | Arrow International Inc Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF. Terminated |
FOZ | None listed |
| Jun 19, 2012 | Arrow International Inc Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A
The multiple-lumen pressure injectable catheter permits venou Terminated |
FOZ | None listed |
| Sep 25, 2010 | Arrow International Inc Multi-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue PLUS Catheter and Sharps Safety Features Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.