Home / Recalls / Baxter Healthcare Corp. / D-0863-2016

D-0863-2016 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

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
334,560 bags

Product Description

Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.

Reason for Recall

Presence of Particulate Matter: identified as a cloth fiber.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: P339135, Exp 08/31/2017

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  • Z-0670-2017 Class II — sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum In (September 28, 2016)
  • Z-0671-2017 Class II — Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infus (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-1840-2016 Class II — COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular re (May 12, 2016)
  • Z-1839-2016 Class II — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; 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)