Biomedical Polymers Recalls Manual Diff Droppers Due to Cannula Failure
Biomedical Polymers is recalling Manual Diff Droppers because the metal cannula may break or fail to pierce blood specimen tubes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The defect involves mechanical failure affecting sample preparation rather than direct patient injury or contamination.
Plain-English summary
Biomedical Polymers, Inc. is recalling 2,052,000 units of Manual Diff Droppers, Part Number CHB4001, which are used for preparing blood samples. The recall covers units with lot numbers 20180709A1C and 20180717A1C, identified by UPC (01) 50885380116009. These products were distributed nationwide in the United States.
The recall is being issued because the metal cannula of the device may break, leaving a broken piece in the blood specimen tube, or it may slide back into the plastic portion of the device instead of piercing the tube. This defect can compromise the integrity of the blood sample preparation process.
Consumers and healthcare facilities should stop using the affected Manual Diff Droppers immediately. Users should contact Biomedical Polymers, Inc. for instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
- Manufacturer
- Biomedical Polymers, Inc.
- Affected units
- 2,052,000
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 (2)
- UPC: (01) 50885380116009 Lot numbers: 20180709A1C
- 20180717A1C
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Biomedical Polymers, Inc. 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.
See all 2 products in this recall →Related recalls
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