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U.S. Department of Health and Human Services

Class 2 Device Recall Prismaflex

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 Class 2 Device Recall Prismaflexsee related information
Date Initiated by FirmMarch 14, 2011
Date PostedApril 06, 2011
Recall Status1 Terminated 3 on September 01, 2011
Recall NumberZ-1901-2011
Recall Event ID 58208
510(K)NumberK072093 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
ProductPrismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.
Code Information All units with Version 3.20 software.
Recalling Firm/
Manufacturer		 Gambro Renal Products, Incorporated
14143 Denver West Pkwy
Lakewood CO 80401-3266
For Additional Information Contact
303-222-6566
Manufacturer Reason
for Recall		Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure.
FDA Determined
Cause 2		Software change control
ActionThe firm, GAMBRO Renal Products, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated March 14, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were provided with response procedures to use if the frozen screen problem occurs while using the product. The customers were instructed to closely monitor the return line for potential air and/or clots in the circuit; review the instructions provided in the attached copy of Chapter 5: Troubleshooting, "Softkeys won't work." of the Prismaflex Operators Manual in conjunction with the attached Troubleshooting Checklist; be aware if performing Manual Termination with Blood Return, air detection is not provided, and complete and return the Customer Reply Form via fax to: Regulatory Affairs at 1-866-447-4471 or 303-222-6916, or by email to: GRPRegulatory.Affairs@us.gambro.com. If you have any questions or concerns, please contact for Clinical questions: ICON 800-554-1312 (available 24/7) or your local Gambro Representative; for Technical questions: Gambro Customer Support 800-525-2623, option 2 (Available 6:00am to 5:30pm MT, Monday thru Friday).
Quantity in Commerce1300 units
DistributionNationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KDI
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