Medline Blood Culture Kits recalled due to mismatched component expiration dates
Medline Industries is recalling 1,600 blood culture kits (Reorder # DYNDH1592) because component expiration dates don't match the kit label. Affected components include CHG Solution and Bactec bottle plastic.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves blood culture kits, which are risk-of-harm products used for critical diagnostics. Expiration date discrepancies on components create uncertainty about product validity and could result in use of compromised kits. No illnesses or injuries have been reported, which limits the severity to a maximum of 3 per the rubric.
Plain-English summary
Medline Industries, LP (Northfield) is recalling 1,600 Adult Blood Culture Collection kits (Reorder # DYNDH1592). The kits contain CHG Solution and Bactec bottle plastic components whose expiration dates do not match the expiration date listed on the kit label.
This discrepancy creates confusion about whether components meet expiration requirements. Healthcare facilities and laboratories may be uncertain about the validity and reliability of affected kits.
The affected kits (Lot Numbers 22GME974 and 22FMF309) were distributed in California. Facilities that received these kits should verify the lot numbers and contact Medline Industries if affected products are identified.
The recalled product
- Product
- MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- expiration-date-mismatch
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI (01)40193489497220 (case)
- (01)10193489497229 (kit)
- Lot Numbers: 22GME974
- 22FMF309
Distribution
Distributed nationwide across the United States.
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