FDA Recall
Open, Classified
Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
Recall: Z-1917-2024
·
Initiated March 1, 2024
Recall
- Recall Number
- Z-1917-2024
- Event Number
- 94448
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- FEI Number
- 1417592
- Product Code
- LRP
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- March 1, 2024
- Posted
- May 29, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
Reason
Trumpet Needle Guide ring can detach when excessive pressure is applied.
Action
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.
Distribution
US Nationwide distribution.
Quantity
30 units