Infusion Pump I.V. Administration recall
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit…
Why was Infusion Pump I.V. Administration recalled?
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: 240100401, Lot number (UDI Number): 897525H (20887787009259, 10887787009252), 905915H (20887787009259, 10887787009252), 926235H (20887787009259, 10887787009252)
- Product
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit…
- Recalling firm
- ICU Medical Inc
- Quantity
- 4,600 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.
- Recall date
- October 23, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)