Sterile blood collection tubes recalled for weak seal defect
MEDLINE INDUSTRIES is recalling Centurion 10mL sterile blood collection tubes due to weak seals that may compromise sterility and allow contamination if they fail.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall of a medical device with potential risk to patient safety through sterility breach and sample contamination. However, no illnesses or injuries have been reported, and the hazard is theoretical—the defect presents risk only if the seal fails during use. Per the rubric, risk-of-harm products without reported harm are scored at High (3).
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling Centurion sterile blood collection tubes, 10mL (Product Code 6430ST). Approximately 1,350 units have been distributed worldwide, including the United States, Panama, and Canada. Affected lot numbers are 2023042690 and 2023103090.
The recalled product may have a weak seal that could result in a breach of sterility if the seal fails. Because the weak seal may not be detectable by all users, healthcare providers and consumers may unknowingly use compromised tubes.
A breach in sterility could allow contamination of blood samples, potentially affecting test results and patient care. Anyone who has received these tubes or is unsure of their product lot should contact MEDLINE INDUSTRIES or the FDA.
The recalled product
- Product
- Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,350
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 20653160172663 (case)
- 00653160172669 (each)
- Lot Numbers: 2023042690
- 2023103090
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 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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