FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
- Recall number
- Z-0948-2022
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
- Status
- Terminated
- Initiated
- 2022-02-25
- Posted
- not on file
- Terminated
- 2026-03-02
- Reason
- Product is mislabeled as self-righting Luer slip tip caps, yellow.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Lot numbers 60268365, 60268609, 60268610, exp. date 10/31/2023; UDI 0085412478852.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYX
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- 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