Recall Z-1407-2021
Medline Industries Inc · initiated March 15, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000
Reason for recall
Possible false negative or false positive results due to the product being compromised during shipment.
FDA-determined cause: Storage
Action taken
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.
Details
- Recall number
- Z-1407-2021
- Initiated
- March 15, 2021
- Product code
- JIN – Nitroprusside, Ketones (Urinary, Non-Quant.)
- Quantity
- 24 each
- Distribution
- US Nationwide distribution in the state of Ohio.
- Recalling firm
- Medline Industries Inc, Northfield, IL