Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
This recall is currently active, issued January 28, 2025. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- November 18, 2024
- Posted
- January 28, 2025
- Recall Number
- Z-1042-2025
- Quantity
- 250 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Distribution
US Nationwide distribution.
Lot / Code Info
1) DYNDC3188: UDI/DI 10653160348818 (each) 00653160348811 (case), Lot Numbers: 2024030690, 2024041990, 2024082390.
Root Cause
Under Investigation by firm
Action Taken
Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2024 via USPS and email. The notice explained the reason for the recall and requested quarantine of affected products pending correction. The firm requested the completion of the response form, which upon receipt, Medline will send labels to affix to the affected products with the instructions for the consignee to remove the affected component prior to using the kit.