Reported Dec 30, 2020 · Ongoing
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/…
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?
28 of 28 products
| Model / number | Product as published |
|---|---|
20123-01 | 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros |
CH3035 | 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger |
CH3135 | 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros w/Red Cap |
CH3156 | 114" Bifuse Primary Set w/2 Spiros, Bag Spike, 2 20 Drop In-line Drip Chamber, Clave, Bag Hanger |
CH3240 | 18 IN (46 cm) Appx 2.9 ml, Add-On Set w/Spiros, Clave Spike, Clamp, Cap |
CH3290 | 27" (69 cm) Appx 5.2 ml, Bifuse Add-On Set w/15 Drop Drip Chamber, Spiros w/Red Cap, Check Valve, Vented Cap, Bag Hanger |
CH3294 | Secondary IV Oncology Kit |
CH3322 | 30 IN (76 cm) Appx 1.8 ml) Ext Set w/2 Spiros, 2 Red Caps, Clamp |
CH3327 | 40" (102 cm) Appx 4.6 ml, Admin Set, 2 Spiros w/2 Red Caps, 20 Drop In-Line Drip Chamber, 2 Bag Hangers |
CH3373 | Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port |
CH3397 | 45" (114 cm) Appx 5.8 ml, Ext Set w/MicroClave, 2 Clave, Spiros w/Red Cap, 2 Clamps |
CH3403 | Oncology Kit w/20" (51 cm) Ext Set w/MicroClave, Graduated Connector, Transfer Set w/Clave Additive Port, Spiros, Red Cap, 13mm Vial Spike w/Clave |
CH3507 | Oncology Kit w/Clave Universal Vented Vial Spike, Spinning Spiros w/Red Cap |
CH3546 | 22" (56 cm) Add-On 150 ml Burette Set (MicroClave, No Shut-Off), w/Spiros, 2 Clamps, Vented Cap |
CH3554 | 4.5 IN (11 cm) Appx 0.43 ml, Ext Set, Spiros w/Red Cap |
CH3559 | Oncology Kit w/Spinning Spiros, C-Clip, Red Cap |
CH3581 | 5 IN (13 cm) Appx 0.57 ml, Ext Set, Anti-Siphon Valve, Spiros |
CH3582 | Oncology Kit w/Spinning Spiros w/Red Cap, C-Clip; Priming Cap |
CH3589 | 77" (196 cm) Appx. 9.4 ml, Admin Set w/2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber, Bag Hanger |
CH3639 | 22" (56 cm) Appx 5.6ml, Ext Set, Trifuse w/4 Clave Clear, Spiros w/Red Cap, 1.2 Micron Filter, 4 Clamps |
- Lot codes and dates
- Lots
70 of 70 codes
472684747646184749803488257847194154858408476325447997464909239476326348078514849307471135747342984784307487704046037464751052480906847197804887803490287747412454773197479353448535864603189474989548003024749463475109847755324853625487713349028844726180475191947633254742008476332848774064902270458999647412734751930476407848493984894536474201747843314894544477412747195764787217490840647528474866868490841548548404853711
- Lots
- Amount recalled
- 55000
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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