Recall Z-0287-2020— Biomedical Polymers, Inc.
Class III · Terminated
Class III FDA medical device recall by Biomedical Polymers, Inc., initiated 2019-09-18, terminated 2020-09-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.. Reason: The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube..
- Recalling firm
- Biomedical Polymers, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-09-18
- Terminated
- 2020-09-15
- Firm location
- Sterling, MA, United States
Product description
Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
Reason for recall
The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
Data sourced from openFDA. This site is unofficial and independent of the FDA.