ICU Medical, Inc. 2022-09-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1723-2022
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED… Recall
Issued September 21, 2022 · ICU Medical, Inc.
In September 2022, ICU Medical, Inc. recalled the 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
What you should do
- 1 Stop using 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact ICU Medical, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- ICU Medical, Inc.
- Category
- Health
- Recall date
- September 21, 2022
- Units affected
- Not reported
- Sold at
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,
- Recall number
- FDA-Z-1723-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- ICU Medical, Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.