CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760

FDA device recall Z-1015-2023 · posted 2023-01-25 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

The kit contained an expired component.

Action taken

Medline Industries issued a DEVICE RECALL notice to its consignees on 12/23/2022 by First Class Mail. The notice explained the problem and requested the following: "REQUIRED ACTION: -Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. -If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OXQ

Quantity affected

1050 kits

Distribution

US Nationwide distribution in the states of NY, IN, FL, NJ, IL.

Date initiated

2022-12-23

Date posted

2023-01-25

Location

Northfield, IL