Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central… recallZ-0649-2018 · Arrow International Inc · initiated Oct 17, 2017

Class II Terminated All recalls posted in February 2018

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

These finished good kits may contain the incorrect Springwire Guide (SWG).

FDA root cause category: Process control

What the company is doing

On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.

Recall details

Recall number: Z-0649-2018
Recall class: Class II
Status: Terminated
Initiated by the company: Oct 17, 2017
Posted by the FDA: Feb 20, 2018
Recalling firm: Arrow International Inc
Quantity: 5,926 total
Product code: FOZ
FDA submissions: K071538
Distribution: Distribution US Nationwide

Product description

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

Code information (models, lots, serial numbers)

Lot numbers: Product Code ASK-45703-PNHS: 23F16M0498 Product Code ASK-45703-PGMCL: 23F17A0505 Product Code ASK-45703-PNW: 23F17B0116

Other devices under the same FDA submission

231 devices cleared under K071538 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

ARROW IPN038522
Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
3 recalls1 report
ARROW IPN931283
Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
3 recalls0 reports
ARROW IPN931284
Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
3 recalls0 reports
ARROW IPN931286
Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
3 recalls0 reports
ARROW IPN036445
Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
2 recalls8 reports
ARROW IPN915628
Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
2 recalls5 reports
ARROW IPN915630
Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
2 recalls2 reports
ARROW IPN036474
Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
2 recalls1 report
ARROW IPN904896
Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
2 recalls1 report
ARROW IPN038523
Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
2 recalls1 report
ARROW IPN055818
Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
2 recalls1 report
ARROW IPN055820
Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
2 recalls1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 79197).

Z-0647-2018 · Terminated
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018
Z-0648-2018 · Terminated
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
Z-0650-2018 · Terminated
Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
Z-0651-2018 · Terminated
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 20…
Z-0652-2018 · Terminated
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dat…
Z-0653-2018 · Terminated
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
Z-0654-2018 · Terminated
Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
Z-0655-2018 · Terminated
AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
Z-0656-2018 · Terminated
ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
Z-0657-2018 · Terminated
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Z-0658-2018 · Terminated
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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