Reported Dec 30, 2020 · Ongoing
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning…
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?
12 of 12 products
| Model / number | Product as published |
|---|---|
20124-01 | 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger |
20130-01 | Spinning Spiros Closed Male Luer, Red Cap |
CH2000S | Spinning Spiros, Closed Male Luer |
CH2000S-10 | Spinning Spiros Closed Male Luer, 10 units |
CH2000S-C | Spinning Spiros Closed Male Luer, Red Cap |
| — | Spiros, Closed Male Luer w/Red Cap, 10 Units, RES: CH2000SC-10 |
CH2000SC-5 | Spiros, Closed Male Luer w/Red Cap, 5 Units |
CH2000S-PC | Spinning Spiros Closed Male Luer, Purple Cap |
034-CH2000S-PC | Conector macho cerrado Spinning Spiros, tapon purpura |
CH2000S-PCP | Spiros, Purple Cap, Drop-In Priming Cap |
CH3515 | Spinning Spiros Closed Male Luer w/Red Cap |
Z7072 | Spinning Spiros Closed Male Luer |
- Lot codes and dates
- Lots
97 of 97 codes
474974547646224790769480629848656634712177474975447579814764633479355949031944726692475678648001854895432472669547497304757614476187847847404794303489543547135144713516474975047497554750947475095047509524757618476317848068324806838484919548583814895446471193247267094756789476189947837634858387496229947267114749767477470547847574795443485777847274464749771471193747274504882569474199947577134793544490866247497454764622
- Lots
- Amount recalled
- 1856578
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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