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U.S. Department of Health and Human Services

Class 2 Device Recall Diluent, StatSite BHB, 6x 3ML

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  Class 2 Device Recall Diluent, StatSite BHB, 6x 3ML see related information
Date Initiated by Firm March 15, 2021
Create Date April 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-1407-2021
Recall Event ID 87561
Product Classification Nitroprusside, ketones (urinary, non-quant.) - Product Code JIN
Product Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
Code Information Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		 Possible false negative or false positive results due to the product being compromised during shipment.
FDA Determined
Cause 2		 Storage
Action The firm sent an Urgent Recall Notification to its customers on 3/15/21 with the following instructions: 1. Immediately check your stock for the affected item number and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your account will receive credit, if applicable. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication.
Quantity in Commerce 24 each
Distribution US Nationwide distribution in the state of Ohio.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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