Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Health...

FDA Recall #Z-0871-2015 — Class II — December 4, 2014

Recall #Z-0871-2015 Date: December 4, 2014 Classification: Class II Status: Terminated

Product Description

Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile

Reason for Recall

Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.

Recalling Firm

Baxter Corporation Englewood — Englewood, CO

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

54,000

Distribution

Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees.

Code Information

Product Code H93869100, Lot 1001380 and Product Code H93866100, Lot 1001365

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated