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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter SelfRighting Luer Lock Tip Cap

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 Class 2 Device Recall Baxter SelfRighting Luer Lock Tip Capsee related information
Date Initiated by FirmDecember 04, 2014
Date PostedDecember 24, 2014
Recall Status1 Terminated 3 on November 30, 2016
Recall NumberZ-0871-2015
Recall Event ID 69934
Product Classification Dispenser, liquid medication - Product Code KYX
ProductSelf-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
Code Information Product Code H93869100, Lot 1001380 and Product Code H93866100, Lot 1001365
Recalling Firm/
Manufacturer		 Baxter Corporation Englewood
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionBaxter 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 in Commerce54,000
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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