FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
- Recall number
- Z-1213-2023
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
- Status
- Open, Classified
- Initiated
- 2023-02-01
- Posted
- 2023-03-03
- Terminated
- not on file
- Reason
- MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.
- Root cause
- Process control
- Action
- Baxter Healthcare initiated the recall by issuing an Urgent Medical Device Recall notice to its consignees by letter on 02/01/2023. The notice requested the following from customers: 1. Check your stock and set aside all product with the affected lot numbers. 2. Contact Baxter HomeCare Services to arrange for return of impacted product and for ordering replacement product. 3. If all of your product is impacted by this recall and you are unable to get unaffected lot numbers, resulting in a significant delay in therapy, please follow the below steps: a. Contact your clinic for clinical guidance and check each pouch and do not use the MiniCap contained inside of any pouches that appear to have damaged seals. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday." Recall was expanded and Baxter Healthcare sent an updated notification to customers and patients on 05/09/2023. The letter instructed consignees and patients to immediately cease use of the affected product, arrange for the return of affected product and assess each patient's individual next steps based on clinical evaluation. Customers were also instructed to complete the customer response form via the portal (for products directly received from Baxter) or through the distributor. If the products were further distributed, please notify customers.
- Quantity
- 33,866,400 units
- Distribution
- US Nationwide distribution and Canada.
- Lot, serial or model codes
- UDI/DI 00085412007694, Lot numbers: GD912051, exp 31-Mar-2024; GD912068, exp 30-Apr-2024; GD912099, exp 30-Apr-2024; GD912112, exp 30-Apr-2024; GD912143, exp 30-Apr-2024; GD912204, exp 31-May-2024. Expansion on 05/10/2023: Product Code 5C4466P with all lots numbers manufactured prior to 09/30/2022.
- 510(k) numbers
- ["K152129"]
- PMA numbers
- not on file
- Product code
- KDJ
- 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