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Prismaflex recallZ-0277-2020 · Baxter Healthcare Corporation · initiated Oct 4, 2019

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

FDA root cause category: Software design

What the company is doing

Baxter Healthcare notified customers on about 10/04/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that Prismaflex Control Units with software versions 7.20 and below have the potential to produce communication errors. Instructions included that operators may continue to use the control units until the upgrade is performed, but if a communication error alarm does occur, follow the instructions presented on the graphical user interface and/or in the operators manual. It must be reinforced that it is important to manually return the extracorporeal blood to the patient, and re-train users on this process, outlined on page 10:57 of the operators manual, if necessary. A local Baxter service representative will contact your facility to determine the correction plan and schedule the software upgrade. If the affected devices was purchased from Baxter, complete the provided Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to [email protected]. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. For a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures. Questions regarding this recall can be directed to Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.

Recall details

Recall number
Z-0277-2020
Status
Open, Classified
Initiated by the company
Oct 4, 2019
Recalling firm
Baxter Healthcare Corporation
Quantity
986 units
Product code
KDI
FDA submissions
K072093
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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. International distribution to Australia, Bangladesh, Brunei, China, Hongkong, Indonesia, India, Japan, New Zealand, Taiwan, Korea, Singapore, Malaysia, Macau, Thailand, Vietnam, Canada, Argentina, Costa Rica, Cuba, Dominican Republic, Haiti, Barbados, Venezuela, St. Kitts, and EMEA.

Product description

Prismaflex Control Unit, software versions below 7.21

Code information (models, lots, serial numbers)

Product Code: 113081; All Lot numbers; GTIN: 07332414105266

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 83852).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page