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Recall Observatory FDA recall evidence

Device product

Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY

Z-0150-2025

September 04, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95415
Status
Ongoing
Classification
Class II
Quantity
168 units
Official record key
device-enforcement:Z-0150-2025

Official wording

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information: a) UDI/DI 40653160270929 (each), 10653160270928 (case), Lot Numbers: 23LBO858; b) UDI/DI 40653160284346 (each), 10653160284345 (case), Lot Numbers: 23LBL653

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile product if the vendor seal of the pouch is opened/unsealed