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U.S. Department of Health and Human Services

Class 2 Device Recall PrismaSate

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  Class 2 Device Recall PrismaSate see related information
Date Initiated by Firm May 23, 2016
Date Posted June 24, 2016
Recall Status1 Terminated 3 on March 28, 2017
Recall Number Z-2049-2016
Recall Event ID 74226
510(K)Number K072908  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Code Information Listing #D051124, Unique Device Identifier #07332414037048, Product code #105351. Lot code (Exp date): 1000123133 (02/28/2017), 1000128162 (04/30/2017), 1000128163 (04/30/2017), 1000128164 (04/30/2017).
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Presence of leaks near top of the PrismaSate bags
FDA Determined
Cause 2		 Other
Action Baxter Healthcare Corporation sent an Urgent Product Recall communication to affected customers via U.S.P.S. first class mail on 05/23/2016.
Quantity in Commerce 10,054 units
Distribution Distributed to Columbia and the following US states: AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KPO and Original Applicant = GAMBRO RENAL PRODUCTS
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