Atlas FDA

Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray

FDA device recall Z-1917-2024 · posted 2024-05-29 · Open, Classified

Recall details

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Reason for recall
Trumpet Needle Guide ring can detach when excessive pressure is applied.
Action taken
Medline issued a correction notice to its consignees on 03/01/2024 via email and USPS first class mail. The notice explained the issue and requested the consignee identify and quarantine all affected products, and respond to the notice. Once the response was received Medline would provide labels to place over the affected product in stock. If the product was further distributed the party which distributed the product was directed to notify their customers.
Root cause
Process control
Status
Open, Classified
Product code
LRP
Quantity affected
30 units
Distribution
US Nationwide distribution.
Date initiated
2024-03-01
Date posted
2024-05-29
Location
Northfield, IL

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