Class 3 Device Recall HemoDrop

• Date Initiated by Firm: September 18, 2019
• Create Date: November 05, 2019
• Recall Status: Terminated on September 15, 2020
• Recall Number: Z-0286-2020
• Recall Event ID: 83965
• Product Classification: Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
• Product: Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.
• Code Information: UPC: (01) 20885380116008 Lot: 20180717A1
• Recalling Firm/ Manufacturer: Biomedical Polymers, Inc.; 16 Chocksett Rd; Sterling MA 01564-2336
• For Additional Information Contact: 978-632-2555
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 108,000
• Distribution: US nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.