Recalls / Class II
Class IID-0351-2019
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.
- Brand name
- Dianeal Low Calcium With Dextrose
- Generic name
- Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose
- Active ingredients
- Calcium Chloride, Dextrose Monohydrate, Magnesium Chloride, Sodium Chloride, Sodium Lactate
- Route
- Intraperitoneal
- NDCs
- 0941-0409, 0941-0411, 0941-0413, 0941-0415, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424 +5 more
- FDA application
- NDA017512
- Affected lot / code info
- Lot #: Y281477, Expiry: 02/2020
Why it was recalled
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Manufacturer
- Vantive US Healthcare LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 29,370 bags
- Distribution pattern
- Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
Timeline
- Recall initiated
- 2019-01-02
- FDA classified
- 2019-01-08
- Posted by FDA
- 2019-01-16
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0351-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.