Recall Z-0286-2020 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Biomedical Polymers, Inc.
Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.
| Date | Sep 18, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Component change control |
| Action | On September 18, 2019 the firm distributed Recall Communication letters by certified mail with the following instructions. To implement this recall, please take the following actions: 1. Immediately examine inventory and quarantine product subject to recall. 2. Immediately discontinue use and distribution of the identified lot number. - A credit memo will be issued covering the quantity of your product returned, or, - We will issue a certificate of destruction to scrap the product on-site or, 3. Return product to: Biomedical Polymers, Inc. ATTN: Maureen Peterso |
| Quantity | 108,000 |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.