Baxter MiniCap Disconnect Cap with Povidone-Iodine… recallZ-1213-2023 · Baxter Healthcare Corporation · initiated Feb 1, 2023

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number

Z-1213-2023

Status

Open, Classified

Initiated by the company

Feb 1, 2023

Posted by the FDA

Mar 3, 2023

Recalling firm

Baxter Healthcare Corporation

Quantity

33,866,400 units

Product code

KDJ

FDA submissions

K152129

Distribution

US Nationwide distribution and Canada.

Product description

Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• MINICAP WITH POVIDONE-IODINE SOLUTION 5C4466P

  Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  1 recall4 deaths347 reports

Other devices under the same FDA submission

1 device cleared under K152129 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Minicap EZPC4466

  Vantive US Healthcare LLC · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  3 reports