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U.S. Department of Health and Human Services

Class 2 Device Recall SelfRighting Luer Slip Tip Cap (DISCPAC)

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  Class 2 Device Recall SelfRighting Luer Slip Tip Cap (DISCPAC) see related information
Date Initiated by Firm February 25, 2022
Create Date April 15, 2022
Recall Status1 Open3, Classified
Recall Number Z-0948-2022
Recall Event ID 89682
Product Classification Dispenser, liquid medication - Product Code KYX
Product Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Code Information Lot numbers 60268365, 60268609, 60268610, exp. date 10/31/2023; UDI 0085412478852.
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Product is mislabeled as self-righting Luer slip tip caps, yellow.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The recalling firm issued letters dated 2/25/2022 via first class mail to the U.S. consignees. The letter explained the reason for recall, described the affected product, the hazard involved, and the actions to be taken by the customer. Those actions included to immediately check their inventory and segregate the affected product, which had a notation that if there are Luer lock tip caps co-mingled with Luer slip tip caps in the same DISCPAC container, please discard the DISCPAC container and that tip caps that are not co-mingled can continue to be used safely following good pharmacy practices. If the consignee received the letter directly from Baxter, they are to acknowledge receipt by responding on the customer portal. If the product was purchased from a distributor, they only need to respond to the distributor or wholesaler according to their instructions. If the product was further distributed to other facilities or departments within their institution, they were instructed to forward a copy of the letter to them. If the customer is a dealer, wholesaler, distributor/reseller, or original equipment manufacturer that distributed the affected product to other facilities, they are to distribute the notification to them. A Reply Form Instruction Sheet was enclosed which outlined the details of the affected product and Baxter Field Action Portal Acknowledgement Instructions. Notification of OUS consignees began 2/25/2022 via mail, email, or FAX.
Quantity in Commerce 5,500 DISCPACs (100/DISCPAC).
Distribution Worldwide distribution - US Nationwide distribution in the states of FL, GA, IL, IN, MO, PA, TX, and VA. The countries of Canada, Austria, Germany, Netherlands, Qatar, Saudi Arabia, and Spain.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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