WebNov 10, 2024 · 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 = KDJ and Original Applicant = Baxter ... WebMay 31, 2024 · Class 2 Device Recall REVACLEAR 400. Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis. There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. The firm, Baxter, sent an " Urgent Product Recall" letter on 05/31/2024.

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WebJul 26, 2024 · The FDA’s recall is based on five complaints that allege the software poses a risk to patients through printed labels it produces for compounded medication mixtures. They sometimes contain... how are group rules created

Class 2 Device Recall Baxter CAPD System Transfer Set

WebJul 22, 2024 · 1 Baxter Pkwy Deerfield IL 60015-4625: For Additional Information Contact: Center for One Baxter 800-422-9837 Manufacturer Reason for Recall: There is a potential of the packaging not maintaining a sterile barrier for the tip caps. FDA Determined Cause 2: Under Investigation by firm: Action: Baxter notified its direct consignees by letter on 07 ... WebJul 26, 2024 · Medical device giant Baxter International is recalling medication administrating software after complaints that it is sometimes recommending the wrong … WebDate FDA Received: 04/13/2024: Is this an Adverse Event Report? No Is this a Product Problem Report? Yes Device Operator: Device Catalogue Number: ZMC7401: Device Lot Number: 20H13V493: Was Device Available for Evaluation? No Is the Reporter a Health Professional? Yes Date Manufacturer Received: 03/21/2024 how are grits served