CLASS II ONGOING Device recall · Reported 23 Oct 2024 · FDA Enforcement Report
Medline Kit Cv I Ii recalled by MEDLINE INDUSTRIES, LP
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kit Cv I Ii, distributed nationwide in the US. The recall was initiated on 28 Aug 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-0123-2025
- FDA event ID
- 95393
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Aug 2024
- FDA classified
- 17 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 28 Aug 2024 | Recall initiated by company | |
| 17 Oct 2024 | Classified by FDA | +50 days |
| 23 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Product as listed by the FDA
MEDLINE KIT CV I II, REF DYNJ906071B
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Medline Kit Cv I Ii recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Kit Cv I Ii on 28 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-0123-2025.
Why was it recalled?
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Which lots are affected?
UDI/DI 40195327227235 (case), 10195327227234 (each), Lot Numbers: 24ABA223
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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