Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-0286-2020·Announced 2019-11-13

Biomedical Polymers Recalls Hemo-Drop Blood Dispensers Due to Metal Cannula Defect

Biomedical Polymers, Inc. is recalling 108,000 Hemo-Drop Blood Dispensers because the metal cannula may break or fail to pierce the specimen tube.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The defect involves a mechanical failure that compromises sample integrity rather than a direct safety hazard to the patient.

Plain-English summary

Biomedical Polymers, Inc. is recalling 108,000 units of the Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP. The device is used for preparing blood samples and was distributed nationwide in the United States. The specific lot number is 20180717A1, and the UPC is (01) 20885380116008.

The recall was initiated 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.

Healthcare facilities and laboratories that have purchased or received these devices should stop using them immediately. Users should contact Biomedical Polymers, Inc. for instructions on how to return the affected units for a refund or replacement. The recall is classified as Class III by the FDA, indicating that the defect is not likely to cause adverse health consequences.

The recalled product

Product: Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.
Manufacturer: Biomedical Polymers, Inc.
Category: Medical Device — Laboratory Equipment
Hazard: mechanical-failure
sample-contamination
Affected units: 108,000

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 (1)

UPC: (01) 20885380116008 Lot: 20180717A1

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 →

Same manufacturer · Biomedical Polymers, Inc.

See all →

Moderate
Biomedical Polymers Recalls Manual Diff Droppers Due to Cannula Failure
FDA (Devices) · 2019-11-13

Same hazard · mechanical failure