FDA Enforcement
Class II
Terminated
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
Recall: Z-0871-2015
·
Reported December 31, 2014
Enforcement
- Recall Number
- Z-0871-2015
- Event ID
- 69934
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Baxter Corporation Englewood
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 31, 2014
- Initiation Date
- December 4, 2014
- Classification Date
- December 24, 2014
- Termination Date
- November 30, 2016
- Address
- 14445 Grasslands Dr, Englewood, CO, 80112-7062, United States
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
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.
Code Info
Product Code H93869100, Lot 1001380 and Product Code H93866100, Lot 1001365
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.
Quantity
54,000