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Recall Observatory FDA recall evidence

Drug product

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.

D-0351-2019

January 02, 2019

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 81881
Status
Terminated
Classification
Class II
Quantity
29,370 bags
Official record key
drug-enforcement:D-0351-2019

Official wording

Reason: Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.

Code information: Lot #: Y281477, Expiry: 02/2020

Distribution pattern: Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility