CLASS II ONGOING Device recall · Reported 2 Nov 2022 · FDA Enforcement Report
Medline Blood Cluture Kit recalled by MEDLINE INDUSTRIES, LP
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Blood Cluture Kit, distributed nationwide in the US. The recall was initiated on 9 Sep 2022 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-0122-2023
- FDA event ID
- 90911
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Sep 2022
- FDA classified
- 21 Oct 2022
- Reported
- 2 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 9 Sep 2022 | Recall initiated by company | |
| 21 Oct 2022 | Classified by FDA | +42 days |
| 2 Nov 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
Where it was distributed
US Nationwide distribution in the state of California.
Questions about this recall
Is Medline Blood Cluture Kit recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Blood Cluture Kit on 9 Sep 2022. The recall is Class II and its status is Ongoing. Recall number Z-0122-2023.
Why was it recalled?
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Which lots are affected?
UDI/DI (01)40193489497220 (case), (01)10193489497229 (kit), Lot Numbers: 22GME974, 22FMF309
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 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.
More recalls from MEDLINE INDUSTRIES, LP - Northfield
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| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
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| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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