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D-0861-2016 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-0861-2016 was initiated by Baxter Healthcare Corp. on January 21, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility. The recall status is terminated (terminated February 26, 2018). Affected quantity: 282,080 bags.

Recall Details

Product Type
Drugs
Report Date
June 1, 2016
Initiation Date
January 21, 2016
Termination Date
February 26, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
282,080 bags

Product Description

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

Reason for Recall

Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: P337857, Exp 07/31/16

Other recalls by Baxter Healthcare Corp.

  • Z-3133-2017 Class II — Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 (September 1, 2017)
  • Z-0370-2017 Class II — GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1106 (October 12, 2016)
  • Z-0671-2017 Class II — Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infus (September 28, 2016)
  • Z-0672-2017 Class II — V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spec (September 28, 2016)
  • Z-0670-2017 Class II — sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum In (September 28, 2016)
  • Z-2533-2016 Class II — Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product (June 24, 2016)
  • Z-2049-2016 Class II — PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy (May 23, 2016)
  • Z-1839-2016 Class II — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular re (May 12, 2016)
  • Z-1840-2016 Class II — COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular re (May 12, 2016)
  • Z-1838-2016 Class II — COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular rec (May 12, 2016)

FDA data resources