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U.S. Department of Health and Human Services

Class 3 Device Recall Cardinal Health Manual Diff Dropper

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 Class 3 Device Recall Cardinal Health Manual Diff Droppersee related information
Date Initiated by FirmSeptember 18, 2019
Create DateNovember 05, 2019
Recall Status1 Terminated 3 on September 15, 2020
Recall NumberZ-0287-2020
Recall Event ID 83965
Product Classification Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
ProductManual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
Code Information UPC: (01) 50885380116009 Lot numbers: 20180709A1C, 20180717A1C 
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 2		Component change control
ActionOn 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 Commerce2,052,000
DistributionUS nationwide distribution.
Total Product Life CycleTPLC 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.
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