FDA-Device2024-04-10Class II

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

MEDLINE INDUSTRIES, LP - Northfield
Hazard

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.

Sold states
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Affected count
760 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1434-2024

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