Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen… recallZ-0653-2018 · 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-0653-2018
- 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 Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
Code information (models, lots, serial numbers)
Lot number: 23F17D0182
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 IPN038522Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls1 report
- ARROW IPN931283Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls0 reports
- ARROW IPN931284Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls0 reports
- ARROW IPN931286Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls0 reports
- ARROW IPN036445Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls8 reports
- ARROW IPN915628Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls5 reports
- ARROW IPN915630Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls2 reports
- ARROW IPN036474Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 report
- ARROW IPN904896Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 report
- ARROW IPN038523Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls1 report
- ARROW IPN055818Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls1 report
- ARROW IPN055820Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 79197).
- Z-0647-2018 · TerminatedPressure 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 · TerminatedMulti 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-0649-2018 · TerminatedPressure 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 2…
- Z-0650-2018 · TerminatedMulti Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
- Z-0651-2018 · TerminatedPressure 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 · TerminatedMulti 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-0654-2018 · TerminatedArrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
- Z-0655-2018 · TerminatedAGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
- Z-0656-2018 · TerminatedARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
- Z-0657-2018 · TerminatedCentral Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
- Z-0658-2018 · TerminatedARROWg+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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