8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Reported: September 21, 2022 Initiated: August 1, 2022 #Z-1720-2022
Product Description
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Reason for Recall
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- Total of all affected units = 5,795,989 units
- Distribution
- 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, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam. O.U.S.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;. Recalled by ICU Medical, Inc.. Units affected: Total of all affected units = 5,795,989 units.
Why was this product recalled? ▼
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2022. Severity: Moderate. Recall number: Z-1720-2022.
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