Z-0287-2020Class III

Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples

Name: Z-0287-2020 Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples
Creator: Biomedical Polymers, Inc.
Published: 2019-09-18
License: https://open.fda.gov/license/

Biomedical Polymers, Inc. / initiated 2019-09-18 / Terminated

FDA source

Biomedical Polymers, Inc. began a recall of Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples on 2019-09-18. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0287-2020
Classification: Class III
Status: Terminated
Initiated: 2019-09-18
Posted: 2019-11-05
Terminated: 2020-09-15
Recalling firm: Biomedical Polymers, Inc.
Product: Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
Product code: LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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 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 in commerce: 2,052,000
Distribution: US nationwide distribution.
Product codes and lots: UPC: (01) 50885380116009 Lot numbers: 20180709A1C, 20180717A1C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0287-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0286-2020	Class III	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05
Z-0287-2020	Class III	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05

Product code LXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)