Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
FDA Recall Z-0287-2020 · Posted None
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Recalling FirmBiomedical Polymers, Inc.
Recall StatusTerminated
Product CodeLXG
Date Initiated2019-09-18
Date Terminated2020-09-15
Product Quantity2,052,000
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.
Firm 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.
Root Cause
Component change control
Distribution Pattern
US nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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