CLASS II Device recall · Reported 14 Jun 2017 · FDA Enforcement Report

AGB+ Pressure Injectable Multi-Lumen CVC Kit intended recalled

Arrow International is recalling AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the, distributed nationwide in the US. The recall was initiated on 20 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial number CA-42703-P1A

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2278-2017
FDA event ID: 76937
Recalling firm: Arrow International, Reading, PA
Classification: Class II
Status: Terminated
Recall initiated: 20 Mar 2017
FDA classified: 6 Jun 2017
Reported: 14 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

20 Mar 2017	Recall initiated by company
6 Jun 2017	Classified by FDA	+78 days
14 Jun 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Which lots are affected?

Material number CA-42703-P1A

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

55 other products · FDA event 76937

This product is part of a recall event; the main page for the event is Arrow Pressure Injectable PICC Kit The Arrow International recalled.

Reported	Class	Recall	Company	Reason	Where
14 Jun 2017	CLASS II	Arrow Pressure Injectable PICC Kit The Arrow International recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure Injectable Arrow(R) PICC Kit recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Two-Lumen Hemodialysis Catheterization Kit recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow(R) VPS(R) Access Kit for use recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure Injectable Multi-Lumen Central Venous recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Radial Artery Catheterization Kit recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure Injectable Multi-Lumen Central Venous recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure injectable Jugular Axillo-Subclavian Central CThe recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow Pressure Injectable PICC Kit The Arrow International recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow Pressure Injectable PICC Kit The Arrow International recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure Injectable Arrow(R) PICC Kit recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arterial Line Kit with Sharps Safety Features recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow¿ Access Kit with Maximal Barrier Precautions for use recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow VPS Access Kit with Maximal Barrier Precautions for use recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	QuickFlash Radial Artery/Arterial Line Catheterization Kit recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis recalled	Arrow International	Other	Nationwide
14 Jun 2017	CLASS II	Arrow Pressure Injectable PICC Kit The Arrow International recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Two-Lumen Hemodialysis Catheterization Kit recalled	Arrow International	Other	Nationwide
14 Jun 2017	CLASS II	ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis recalled	Arrow International	Other	Nationwide
14 Jun 2017	CLASS II	Arrow PICC with Chlorag+ard Technology A PICC permits recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Percutaneous Sheath Introducer Kit recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure Injectable Two-Lumen Central Venous recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	MAC(TM) Two-Lumen Central Venous Access Kit recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure Injectable Quad-Lumen Central Venous recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	MAC(TM) Two-Lumen Central Venous Access Kit recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow¿ Access Kit with Maximal Barrier Precautions for use recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow PICC with Chlorag+ard Technology A PICC permits recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	QuickFlash(R) Radial Artery/Arterial Line Catheterization recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Femoral Arterial Line Catheterization Kit The Arrow¿ recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Percutaneous Sheath Introducer Kit recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow(R) Access Kit for use recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure Injectable Multi-Lumen Central Venous recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure Injectable Multi-Lumen Central Venous recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arterial Catheterization Kit The Arrow¿ Arterial recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow(R) VPS(R) Access Kit for use recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Femoral Arterial Line Catheterization Kit The Arrow¿ recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arrow¿ Access Kit with Maximal Barrier Precautions for use recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	"Pressure Injectable Jugular Axillo-Subclavian Central recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Percutaneous Sheath Introducer Kit recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Arterial Catheterization Kit recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit recalled	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Radial Artery Catheterization Kit recalled by Arrow International	Arrow International	Packaging Defects	Nationwide
14 Jun 2017	CLASS II	Pressure Injectable Two-Lumen Central Venous recalled	Arrow International	Packaging Defects	Nationwide

More recalls from Arrow International

All 525

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS I	Description/REF: Agba Picc G4 Stylet: 3L 6FR x 55CM recalled	Arrow International	Sterility	Nationwide
24 Jun 2026Device	CLASS I	Description/REF: Hemodialysis KIT: 2-Lumen 8 FR X 11 CM/AK recalled	Arrow International	Sterility	Nationwide
24 Jun 2026Device	CLASS I	Description/REF: PI CVC KIT recalled by Arrow International	Arrow International	Sterility	Nationwide
24 Jun 2026Device	CLASS I	Description/REF: PI Picc: 3: 6FR x 55CM w CHG/ Dlx-35563-Hpkc; Agba recalled	Arrow International	Sterility	Nationwide
24 Jun 2026Device	CLASS I	Description/REF: Pacing PSI KIT: 6 FR/AI-06210-KS, Pacing PSI KIT recalled	Arrow International	Sterility	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide