Gambro Cartridge Blood Set Prime Line - Product Usage recall
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Why was Gambro Cartridge Blood Set Prime Line - Product Usage recalled?
Potential disconnection of tubing set.
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: 101025; UDI: 37332414007837; Lot Numbers: 1000200708, 1000203117, 1000203118, 1000203119, 1000203120, 1000203121, 1000205678, 1000205897, 1000205898, 1000205899, 1000205900, 1000205901, 1000206872, 1000206873, 1000206874, 1000208247, 1000208248, 1000208249, 1000208250, 1000210314, 1000210315, 1000210316, 1000210317, 1000210318, 1000210319, 1000210320, 1000211719, 1000211720, 1000211721, 1000211722, 1000211723, 1000211724, 1000215485, 1000215486, 1000215487, 1000215488, 1000215489, 1000215490, 1000217361, 1000217362, 1000217363, 1000217364, 1000218866, 1000218867, 1000218868, 1000218869, 1000218870, 1000218871, 1000220529, 1000220530, 1000220531, 1000220532, 1000223070, 1000223071, 1000223072, 1000223073, 1000223074, 1000225427, 1000225428, 1000225429, 1000225430, 1000225431, 1000226714, 1000226717, 1000229599
- Product
- Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 2,361,885 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, Latvia, Montenegro, Morocco, Netherlands, Norway, Poland, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Korea, Singapore, Hong Kong
- Recall date
- June 10, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)