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Recall Observatory FDA recall evidence

Device product

Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535

Z-1434-2024

February 23, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94136
Status
Ongoing
Classification
Class II
Quantity
760 units
Official record key
device-enforcement:Z-1434-2024

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) 66795, UDI/DI 50653160061180 (case) 00653160061185 (each), Lot Numbers: 2023030190, 2023052390, 2023092590; b) 67525, UDI/DI 10653160158639 (case) 00653160158632 (ease), Lot Numbers: 2023032490; c) 37535, UDI/DI 10653160169048 (case) 00653160169041 (each), Lot Numbers: 2023061490

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