Date Initiated by Firm | November 01, 2023 |
Date Posted | November 16, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0314-2024 |
Recall Event ID |
93379 |
Product Classification |
Blood and urine collection kit (excludes HIV testing) - Product Code OIB
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Product | BLOOD CULTURE KIT, REF DYNDH1647B |
Code Information |
UDI/DI 40195327267002 (case), 10195327267001 (unit): Lot Numbers: 23CMH028, 23CMD954
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Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
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For Additional Information Contact | Karin Johnson 886-359-1704 |
Manufacturer Reason for Recall | This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 11/01/2023 via email. The notice explained the issue and requested that the destruction of the affected kits. Consignees were also instructed to notify all parties if the kits were transferred. |
Quantity in Commerce | 1890 kits |
Distribution | US Nationwide distribution in the state of California. |
Total Product Life Cycle | TPLC Device Report |
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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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