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Recall Observatory FDA recall evidence

Device product

Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST

Z-1448-2024

February 23, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94136
Status
Ongoing
Classification
Class II
Quantity
1700 units
Official record key
device-enforcement:Z-1448-2024

Official wording

Reason: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information: a) 15MLVLCP, UDI/DI 50653160021306 (case) 00653160021301 (each), Lot Numbers: 2023102790 b) MG912ST, UDI/DI 10653160122906 (case) 00653160122909 (each), Lot Numbers: 2023022190

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    weak seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of sterility