Polymedco Sediplast Tubes Recalled for Potential Blood Exposure
Polymedco is recalling Sediplast tubes because pressure buildup may eject the cap, releasing blood and creating a biological hazard for operators.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Class II, and the source describes a hazard involving the release of blood and exposure to a biological hazard, but does not report any illnesses, injuries, or deaths.
Plain-English summary
Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC is recalling Sediplast tubes, model numbers S-100 and S-1000. The recall involves 448,400 units distributed nationwide in the United States and in the United Kingdom.
The recall is due to a potential safety hazard where increased resistance during pipette insertion may cause pressure buildup. This pressure can force the tube cap to detach or eject, potentially releasing blood and exposing the operator or surrounding work area to a biological hazard.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Users should stop using the affected tubes and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
- Affected units
- 448,400
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)
- Model/Catalog No. S-100 and S-1000
- UDI-DI: N/A
- Lot Number E1150A
- Expiration Date 06/30/27
Distribution
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