CLASS II ONGOING Device recall · Reported 22 Nov 2023 · FDA Enforcement Report
Central Line Blood Culture Dra recalled by MEDLINE INDUSTRIES, LP
Medline Industries LP - Northfield is recalling Central Line Blood Culture Dra, distributed nationwide in the US. The recall was initiated on 1 Nov 2023 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-0312-2024
- FDA event ID
- 93379
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2023
- FDA classified
- 16 Nov 2023
- Reported
- 22 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Nov 2023 | Recall initiated by company | |
| 16 Nov 2023 | Classified by FDA | +15 days |
| 22 Nov 2023 | 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
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
Product as listed by the FDA
CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
Where it was distributed
US Nationwide distribution in the state of California.
Questions about this recall
Why was it recalled?
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
Which lots are affected?
UDI/DI 40193489402446 (case), 10193489402445 (unit): Lot Numbers: 23DMF156, 23CMH030, 23CMD955
Where was it sold?
US Nationwide distribution in the state of California.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 93379This product is part of a recall event; the main page for the event is Adlt Blood Culture Collect Kit recalled by MEDLINE INDUSTRIES, LP.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Adlt Blood Culture Collect Kit recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Other | Nationwide | |
| CLASS II | Peripheral Blood Culture Draw recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Other | Nationwide | |
| CLASS II | Blood Culture Kit recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Other | Nationwide | |
| CLASS II | 24 Blood Culture Kit recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Other | Nationwide |
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
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|---|---|---|---|---|---|
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| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |