Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the U.S.
Reported: October 23, 2019 Initiated: July 29, 2019 #Z-0142-2020
Product Description
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the U.S.
Reason for Recall
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Details
- Recalling Firm
- ICU Medical Inc
- Units Affected
- 5,443 units
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the U.S.. Recalled by ICU Medical Inc. Units affected: 5,443 units.
Why was this product recalled? ▼
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 23, 2019. Severity: Moderate. Recall number: Z-0142-2020.
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