Z-1213-2023Class II

Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration...

Name: Z-1213-2023 Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration...
Creator: Baxter Healthcare Corporation
Published: 2023-02-01
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-02-01 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis on 2023-02-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1213-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-01
Posted: 2023-03-03
Recalling firm: Baxter Healthcare Corporation
Product: Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 33,866,400 units
Distribution: US Nationwide distribution and Canada.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1213-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1213-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-03

Product code KDJ

K152129Class IIFlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine SolutionBaxter Healthcare Corporation / cleared 2015-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)