Reported Dec 30, 2020 · Ongoing
3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe…
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?
26 of 26 products
| Model / number | Product as published |
|---|---|
CH2003 | 5mL Syringe w/Spinning Spiros, Red Cap |
CH2005 | 10mL Syringe w/Spinning Spiros, Red Cap |
CH2010 | 20mL Syringe w/Spinning Spiros, Red Cap |
CH2020 | 30mL Syringe w/Spinning Spiros, Red Cap |
CH2030 | 60mL Syringe w/Spinning Spiros, Red Cap |
CH2060 | 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger |
CH3011 | 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Red Cap, Hanger |
CH3011-C | 40 IN (102 cm) App 4.8 ml, Admin Set, 20 Drop, 2 Spiros, Bag Hanger |
CH3020 | 14 IN (36 cm) App 4.8 ml, Bifuse Add-On Set, Spiros w/Red Cap, Bag Spike |
CH3033 | 5" (13 cm) Bag Spike Adapter w/Spiros w/Red Cap, Vented Cap |
CH3034 | 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, 0.2 Micron Filter, Spiros w/Red Cap, Hanger |
CH3128 | Oncology Kit w/60" (152 cm) Appx 2.3 ml, Smallbore Ext Set w/Spiros, Anti-Siphon Valve, ChemoClave, Clamp, Rotating Luer, Double ChemoClave Syringe Transfer Set, Spiros w/Red Cap |
CH3606 | 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps |
CH3625 | 86" (218 cm) Appx 10.4 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap |
CH3642 | Oncology Kit w/40" (102 cm) Appx 4.7 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, Double ChemoClave Syringe Transfer Set |
CH3677 | 5.5" (14 cm) Appx 0.55 ml, Smallbore Trifuse Ext Set w/3 ChemoClave, Spiros w/Red Cap, 3 Clamps |
CH3700 | 50 IN (127 cm) Appx 6.4 ml, Ext Set w/ChemoClave, Spiros w/Red Cap, Clamp |
CH3703 | 16 IN (41 cm) Appx 1.6 ml, Ext Set, ChemoClave, Spiros w/Red Cap |
CH3715 | Oncology Kit, Ext w/Spiros, Grad Conn, 2 Vial Spikes w/Clave, Spinning Spiros |
CH3929 | Oncology Kit, w/Ext, MicroClave, Clave, Grad Conn, Transfer, Spiros, Vial Spike, Clave |
- Lot codes and dates
- Lots
106 of 106 codes
455370246054734763191477552048492054549847454877945723144734247476391748492084741169476392145602314750962454985047632004734249479430748068554849220486117648774724605484474978047954484876942471939547371464764825480021048664114800214473426247943084795454480686248492394849248484925146055044719410473427347576654763982479974048611744605074474128247511174809117487714548945384557534473350947412914743763477412047335124865834
- Lots
- Amount recalled
- 534764
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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