Medline Blood Culture Collection Kit Recalled for Expired Bactec Component
Medline Industries recalls specific lots of blood culture collection kits because the Bactec component expiration date was not documented on the kit insert. Users who fail to check the component's expiration date inside the kit risk using an expired diagnostic component.
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 is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical—users who fail to check the Bactec component's expiration date risk using an expired diagnostic component. Per the severity rubric, Class II recalls with theoretical risks and no reported harm score a maximum of 3 (High).
Plain-English summary
Medline Industries, LP is recalling specific lots of its Blood Culture Collection Kit (Reorder Number DYNDH1714A) distributed nationwide in the United States. Approximately 4,320 units are affected, specifically Lot 23KBC138.
The kits were assembled using a Bactec component lot and expiration date that were not accurately reflected on the kit insert documentation. This creates a risk that users, without checking the physical Bactec component inside the kit for its expiration date, could use an expired diagnostic component.
This recall affects healthcare facilities and laboratories that received the affected lot. Medline Industries advises users to check the expiration date printed on the Bactec component inside each kit before use. If you have kits from the affected lot, verify the expiration date of the internal Bactec component before using any kit.
The recalled product
- Product
- MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- expired-component
- 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 (3)
- UDI/DI 40195327347551 (case)
- 10195327347550 (unit)
- Lot Numbers: 23KBC138
Distribution
Distributed nationwide across the United States.
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