Reported Nov 29, 2017 · Terminated

SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer…

ICU Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212

Is this the product you have?

23 of 23 products

Products covered by this recall
Model / numberProduct as published
066-C3352111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip
B3016732" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer
B3024310" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer
B330843-Way High Flow Stopcock w/Rotating Luer
B402038" Non-DEHP Smallbore Ext Set w/2 T-Connectors/Inj Sites, Remv 3-Way Stopcock, 2 Clamps, Luer Slip
B4054300" Ext Set w/Remv 3-Way Stopcock, Check Valve, Clamp, Rotating Luer
B41213 Gang 3-Way Stopcocks w/Rotating Luer
B415433" Ext Set w/Remv 3-Way Stopcock, Luer Lock
B417135" (89 cm) Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer
B4181113" 15 Drop Primary Set w/2 MicroClave, Remv 3 Gang Manifold w/2 1o2, 3 Way Stopcock, Rotating Luer, 1 Ext
B5153131" (333 cm) Appx 17.2 mL, 20 Drop Admin Set w/4 Pre-slit Ports, MicroClave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext
B9900-510101" 15 Drop Primary Set w/2 MicroClave, Rotating Luer, 1 Smallbore T-Connector Ext w/Remv 3-Way Stopcock
B99262140" (356 cm) Appx 18.0 ml, 15 Drop Primary Set w/3 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext
Z0060140" (356 cm) Appx 17.9 mL, 15 Drop Primary Set w/BCV-Clave, 2 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext
Z014340" Ext Set w/Removable 2 Gang 3-Way Stopcocks, Pre-Pierced Port, Clamp, Rotating Luer
Z1746136" (345 cm) Appx 18.0 ml, 10 Drop Primary Set w/3 Inj Sites, Remv 3-Way Stopcock, Rotating Luer, 1 Ext
Z2003137" (348cm) Appx 17.5ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 2 Ext
Z236748" Ext Set w/Remv 3-Way Stopcock, 2 Clave, MicroClave T-Conn, 3 Clamps, Rotating Luer, 1 Ext, Smallbore
Z2722126" 15 Drop Primary Set w/3 MicroClave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 1 Ext
Z2760114" (290 cm) 60 Drop 150ml Burette Set (w/MicroClave Shut Off, Filter), 3 Pre-Slit Ports, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Smallbore Ext Set w/Clave
Lot codes and dates
    • Lot Number 3458321
    • 3462452
    • 3465813
    • 3442569
    • 3446005
    • 3450752
    • 3465816
    • 3456237
    • 3486340
    • 3451451
    • 3447667
    • 3447427
    • 3471329
    • 3462010
    • 3447673
    • 3470589
    • 3466170
    • 3462856
    • 77-979-Y1
    • 76-113-Y1
    • 76-114-Y1
    • 77-981-Y1
    • 77-259-Y1
    • 77-023-HE
    • 77-481-Y1
    • 78-637-HE
    • 77-034-HE
    • 77-222-Y1
    • 77-341-HE
    • 77-354-Y1
    • 77-613-Y1
    • 77-033-HE
    • 76-101-Y1
    • 77-305-HE
    • 76-059-Y1
    • 77-149-Y1
    • 78-466-HE
    • 79-571-JW
    • 77-203-Y1
Amount recalled
24,475 (17,225 in US)

Why it was recalled

ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 17, 2018 · Data as of Sep 19, 6:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.