FDA Medical Device Recalls (openFDA)
Baxter Corporation Englewood: 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 number
- Z-0871-2015
- Recalling firm
- Baxter Corporation Englewood
- Product
- 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
- Status
- Terminated
- Initiated
- 2014-12-04
- Posted
- 2014-12-24
- Terminated
- 2016-11-30
- 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.
- Root cause
- Process control
- Action
- Baxter sent an Urgent Product Recall letter via USPS to all affected customers dated December 8, 2014.The letter identified the product the problem and the action needed to be taken by the customer. Customers are instructed to locate and remove all affected product from their facility, and to contact Baxter Healthcare to arrange for return and credit.Returned products will be destroyed./discarded. If you have questions regarding the content of the communication, please call The Center for One Baxter at (1-800) 422-9837, between the hours of 8:00am and 5:00pm Central time.
- 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.
- Lot, serial or model codes
- Product Code H93869100, Lot 1001380 and Product Code H93866100, Lot 1001365
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYX
- Firm FEI
- 1419106
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28