Home / Recalls / Baxter Healthcare Corp / Z-1840-2016

Z-1840-2016 Class II Terminated

Recalled by Baxter Healthcare Corp — Hayward, CA

FDA device recall Z-1840-2016 was initiated by Baxter Healthcare Corp on May 12, 2016 and is designated Class II. Reason for recall: Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use. The recall status is terminated (terminated March 23, 2017). Affected quantity: 6,128 units.

Recall Details

Product Type
Devices
Report Date
June 8, 2016
Initiation Date
May 12, 2016
Termination Date
March 23, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,128 units

Product Description

COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Reason for Recall

Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.

Distribution Pattern

Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.

Code Information

HA151038, HA151220, HA151037, HA151028, HA160114, HA160115, HA160222

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-0670-2017 Class II — sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum In (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-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-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-1627-2016 Class II — GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752 (April 21, 2016)

FDA data resources