FDA Medical Device Recalls (openFDA)
Biomedical Polymers, Inc.: Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
- Recall number
- Z-0287-2020
- Recalling firm
- Biomedical Polymers, Inc.
- Product
- Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
- Status
- Terminated
- Initiated
- 2019-09-18
- Posted
- not on file
- Terminated
- 2020-09-15
- 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 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
- 2,052,000
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- UPC: (01) 50885380116009 Lot numbers: 20180709A1C, 20180717A1C
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXG
- Firm FEI
- 1220502
- Firm city
- Sterling
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28