Reported Dec 30, 2020 · Ongoing
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set…
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?
36 of 36 products
| Model / number | Product as published |
|---|---|
011-CH2000SC-25 | 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger |
011-CH3185 | 46 cm (18") Appx 7.4 ml, Trifuse Add-On Set w/2 Spiros w/Purple Caps, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter |
011-CH3266 | 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Purple Cap, 20 Drop In-Line Drip Chamber, Bag Hanger |
011-CH3446 | 61 cm (24") Appx 8.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros w/Purple Cap, 3 Clamps (1 Blue, 2 White), Check Valve, Dry Spike Adapter |
011-CH3729 | 25 UNITS of Spiros CLOSED MALE LUER |
011-H2457 | Appx 1.0 ml, Adattatore per Pompa con Spiros |
011-H2629 | 179 cm (70") Appx 11.5 ml, PUR Ambr. Deflussore con Spiros, Camera, BCV, Y-Clave e LL Gir. |
011-H2776 | 180 cm (71IN)APPX 11.5ml,PUR AMBR,Spiros,CAMERA,REG.FLUSSO,BCV,Y-Clave |
011-H2864-HSR | 181cm(71 IN)APPX11.6ml,PUR DEFLUSSORE,Spiros,20 DROP IN LINE,BCV,Clave |
011-H2904 | 38 cm (15 IN) APPX 2.9 ml, TRIFUSE EXT SET, 3 MicroClave, Spiros, PURPLE CAP |
011-H3449 | 42cm(16.5 IN)APPX 2.6ml,PUR TRANSFER SET,Clave ADDITIVE PORT,BCV,Spiros |
011-H3597 | 41cm(16 IN)APPX 2.9ml,PUR SET PERFORATORE,Clave,VALVOLA,Spiros |
011-H3628 | 41cm(16 IN)APPX 3.1ml,SET AMBRATO,PERFORATORE,Clave,VALVOLA,Spiros |
011-H3629 | 42cm(16.5 IN)APPX 5.6ml,SET,PERFORATORE,Clave,FILTRO,VALVOLA,Spiros |
011-H3630 | 109 cm(43 IN) APPX 7.2 ml,KIT,EXT SET W/Spiros,STOPCOCK,5 Clave,4-GANG STOPCOCK |
011-MC330632 | 2 Ext Sets w/5-Gang Stopcock, 9 Clave, Spiros, Stopcock |
011-MC33242 | Kit for multiple transfers |
011-N1000 | Kit per il riempimento pompe elastomeriche con SPIROS / Kit for elastomeric pump priming with SPIROS |
011-N1000-P2 | APPX 2.3ml, ZYTO-VERBINDUNGSLEITUNG (ZYTO-CONNECTING LINE) |
011-N1664SP | Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros |
- Lot codes and dates
- Lots
70 of 70 codes
463084648484154734764473494047520444742983476495748781724808952486750248048004854732478327347730674807223480016848770264752842477343247641944727034484778048766264548846457317148671544515064457411347430104773247484899547408174774162487710649024614711498471993047408354798726486644648944904727444474191847780134800251480688147438404734281477552847997614763261477408047907394749875479459948026724859281471835147270424741435
- Lots
- Amount recalled
- 217522
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
This product could cause temporary or reversible health problems — stop using it.
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