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Recall Observatory FDA recall evidence

Device product

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

Z-1917-2024

March 01, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94448
Status
Ongoing
Classification
Class II
Quantity
30 units
Official record key
device-enforcement:Z-1917-2024

Official wording

Reason: Trumpet Needle Guide ring can detach when excessive pressure is applied.

Code information: UDI/DI 40653160122945 (case), 10653160122944 (unit), Lot Numbers: 23JBX257, 23KMG455

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Trumpet Needle Guide ring can detach when excessive pressure is applied.