FDAClass IIJune 10, 2020

Gambro Cartridge Low Weight-Low Volume Blood Transport recall

Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis…

Why was Gambro Cartridge Low Weight-Low Volume Blood Transport 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: 114435; UDI: 37332414112401; Lot Numbers: 1000212228, 1000215484, 1000224531

Product
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis…
Recalling firm
Baxter Healthcare Corporation
Quantity
4,065
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)
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