CLASS II Device recall · Reported 6 Jun 2018 · FDA Enforcement Report

Percutaneous Sheath Introducer Kit recalled by Arrow International

Arrow International is recalling Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis, distributed nationwide in the US. The recall was initiated on 11 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: Product Code MSO-29802-AHS: 13F17C0408 13F17E0419 13F17F0683 13F17H0283 13F17K0545 Product Code MSO-29903-AHS: 13F17E0607 13F17G0356 13F17K0327 13F17L0350

Quantity recalled416,055 total products

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-2017-2018
FDA event ID: 79890
Recalling firm: Arrow International, Reading, PA
Classification: Class II
Status: Terminated
Recall initiated: 11 Apr 2018
FDA classified: 30 May 2018
Reported: 6 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

11 Apr 2018	Recall initiated by company
30 May 2018	Classified by FDA	+49 days
6 Jun 2018	Published in enforcement report	+7 days

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

Reason for recall

Product sterility may be compromised due to unsealed packaging.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS

Where it was distributed

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Product sterility may be compromised due to unsealed packaging.

Which lots are affected?

Lot Numbers: Product Code MSO-29802-AHS: 13F17C0408 13F17E0419 13F17F0683 13F17H0283 13F17K0545 Product Code MSO-29903-AHS: 13F17E0607 13F17G0356 13F17K0327 13F17L0350

Where was it sold?

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

75 other products · FDA event 79890

This product is part of a recall event; the main page for the event is Catheter Clamp with Fastener recalled by Arrow International.

Reported	Class	Recall	Company	Reason	Where
6 Jun 2018	CLASS II	Catheter Clamp with Fastener recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Catheter Clamp with Fastener recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Maximal Barrier Drape recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Arrow-Flex(R) Percutaneous Sheath Introducer Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Percutaneous Sheath Introducer Kit recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Peel Away Sheath over Dilator recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Maximal Barrier Drape recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Pressure Injectable Multi-Lumen Central Venous recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Multi-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Epidural Needle recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	VPS Rhythm ECG Accessory Pack with Johans Adapter recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Radial Arterial Access Kit recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Arterial Catheterization Kit recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Extension Line Slide Clamps recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Two-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Radial Artery Catheterization Kit with Sharps Safety Features recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Radial Artery Catheterization Kit recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Multi-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Percutaneous Sheath Introducer Kit recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	PICC Catheter Trimmer ; Product recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Arrow PICC Set recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Vps Rhythm ECG Accessory Pack ; Product codes: Rhy-100-Ecgo recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	TheraCath(R) Epidural Catheter recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Catheter Clamp with Fastener recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Maximal Barrier Drape recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Single-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Catheter Clamp with Fastener recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Arrow Jacc with Chlorag+ard Technology recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	MAC(TM) Two-Lumen Central Venous Access Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Percutaneous Sheath Introducer Kit recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Sheath Adapter with Cath-Gard¿ Catheter Contamination recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Arterial Catheterization Kit recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Multi-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Two-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Echogenic Introducer Needle recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Clear Fenestrated Drape with Adhesive recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Multi-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Arrow PICC Set recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Arrow PICC with Chlorag+ard Technology recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Catheter Hemostasis Valve For use with .038" (. dia recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Radiopaque Polyurethane Sheath/Dilator recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	0.2 Micron Flat Epidural Filter recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Arrow-Johans" ECG Adapter for Right Atrial recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Pressure Injectable Multi-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Maximal Barrier Drape recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Multi-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Double-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Echogenic Needle recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Spring Wire Guide Introducer Needle recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	VPS TipTracker Stylet Accessory recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	ARROWg+ard Blue(R) Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Pressure Injectable Multi-Lumen Central Venous recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Pressure Injectable Multi-Lumen Central Venous recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Continuous Nerve Block Needle recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Pressure Injectable Multi-Lumen Central Venous recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	SnapLock" Catheter/Syringe Adapter recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	10 cc Luer-Slip Loss of Resistance Syringe recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Pressure Injectable Quad-Lumen Central Venous recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Arterial Line Kit with Sharps Safety Features recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Pressure Injectable Two-Lumen Central Venous recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Maximal Barrier Drape recalled by Arrow International	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Pressure Injectable Multi-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Spring-Wire Guide Introducer Catheter Assembly recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Radial Artery Catheterization Kit with Sharps Safety Features recalled	Arrow International	Sterility	Nationwide
6 Jun 2018	CLASS II	Single-Lumen Central Venous Catheterization Kit recalled	Arrow International	Sterility	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 Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide