Hemo-Drop Blood Dispenser (Biomedical Polymers) – Cannula Failure (2019)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 Peterson, Sr. QA Manager 16 Chocksett Road Sterling, MA 01564 4. If you may have further distributed this product, please identify those customers and notify them at once of this product recall. Your notification to your customers should include a copy of this recall notification letter. This recall should be carried out to the user level. If you have any questions, please do not hesitate to call our Customer Service at (978) 632-2555, or Maureen Peterson at (978) 632-2555 X 114, M-F 8am 5pm EST.