FDA Medical devices recall ·
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT… recall
- Recall number
- Z-1041-2025
- Date
- (initiated November 18, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1450 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) DYNDC3188: UDI/DI 10653160348825 (each) 00653160348828 (case), Lot Numbers: 2024040390, 2024051490, 2024070590, 2024100790.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1041-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.