Home / Recalls / Baxter Corporation Englewood / Z-1227-2015

Z-1227-2015 Class II Terminated

Recalled by Baxter Corporation Englewood — Englewood, CO

FDA device recall Z-1227-2015 was initiated by Baxter Corporation Englewood on December 29, 2014 and is designated Class II. Reason for recall: Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels. The recall status is terminated (terminated August 8, 2016). Affected quantity: 1,404,230.

Recall Details

Product Type
Devices
Report Date
March 11, 2015
Initiation Date
December 29, 2014
Termination Date
August 8, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,404,230

Product Description

Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.

Reason for Recall

Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.

Distribution Pattern

Nationwide Distribution

Code Information

All DiscPac products are affected within expiry up to October 2017

Other recalls by Baxter Corporation Englewood

  • Z-0007-2017 Class I — 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria (August 24, 2016)
  • Z-0731-2016 Class II — Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syring (December 21, 2015)
  • Z-1628-2015 Class II — ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) (April 8, 2015)
  • Z-0871-2015 Class II — Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yell (December 4, 2014)
  • Z-1847-2014 Class II — Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations (May 28, 2014)
  • Z-1620-2014 Class II — RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): (April 16, 2014)
  • Z-1566-2014 Class I — ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator (April 2, 2014)
  • Z-0539-2014 Class II — ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), (December 3, 2013)

FDA data resources