Home / Recalls / Baxter Healthcare Corp. / D-627-2013

D-627-2013 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-627-2013 was initiated by Baxter Healthcare Corp. on May 21, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue… The recall status is terminated (terminated Jun 18, 2015).

Recall Details

Product Type: Drugs
Report Date: Jul 10, 2013
Initiation Date: May 21, 2013
Termination Date: Jun 18, 2015
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015

Reason for Recall

Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Distribution Pattern

Nationwide & Puerto Rico

Code Information

Lot #: Product code 2B0973: P279935, Exp 7/13

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-627-2013
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Baxter Healthcare Corp.

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