CLASS II ONGOING Device recall · Reported 5 Feb 2025 · FDA Enforcement Report
Medline procedure kits labeled as: Central Line Dressing Kit recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as: Central Line Dressing Kit, distributed nationwide in the US. The recall was initiated on 18 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1042-2025
- FDA event ID
- 96110
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Nov 2024
- FDA classified
- 28 Jan 2025
- Reported
- 5 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Nov 2024 | Recall initiated by company | |
| 28 Jan 2025 | Classified by FDA | +71 days |
| 5 Feb 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Medline procedure kits labeled as: Central Line Dressing Kit recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline procedure kits labeled as: Central Line Dressing Kit on 18 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-1042-2025.
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.
Which lots are affected?
1) DYNDC3188: UDI/DI 10653160348818 (each) 00653160348811 (case), Lot Numbers: 2024030690, 2024041990, 2024082390.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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