Medline Peripheral Blood Culture Draw Kits Recalled Due to Expired Components
Medline is recalling 1,770 Peripheral Blood Culture Draw kits because components within the kits have expired before the kit's stated expiration date.
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 recall involves expired components in a diagnostic medical device where no illnesses or injuries have been reported. The expired components create a risk-of-harm situation through potential diagnostic failure, meeting the rubric criterion for High severity.
Plain-English summary
Medline Industries, LP is recalling 1,770 Peripheral Blood Culture Draw kits (Reference DYNDH1561) with distribution in California. The recalled kits have lot numbers 23EMF711 and 23CMH027.
The kits are being recalled because certain components within each kit have expired before the overall kit expiration date shown on the package insert. Expired components may not perform as intended for proper blood culture collection and preservation.
Healthcare facilities and providers who have received these kits should stop using them immediately. Users with questions should contact Medline Industries for further instructions.
The recalled product
- Product
- PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,770
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 40193489402811 (case)
- 10193489402810 (unit): Lot Numbers: 23EMF711
- 23CMH027
Distribution
Part of a larger recall action
This product is one of 5 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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