Home / Recalls / Baxter Healthcare Corp. / Z-2049-2016

Z-2049-2016 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
July 6, 2016
Initiation Date
May 23, 2016
Termination Date
March 28, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,054 units

Product Description

PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

Reason for Recall

Presence of leaks near top of the PrismaSate bags

Distribution Pattern

Distributed to Columbia and the following US states: AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI

Code Information

Listing #D051124, Unique Device Identifier #07332414037048, Product code #105351. Lot code (Exp date): 1000123133 (02/28/2017), 1000128162 (04/30/2017), 1000128163 (04/30/2017), 1000128164 (04/30/2017).

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-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)
  • Z-1840-2016 Class II — COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular re (May 12, 2016)
  • Z-1629-2016 Class II — GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754 (April 21, 2016)