| Class 2 Device Recall PrismaSate | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KPO
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