FDAFDA · Food and drugs·Recall number Z-1434-2024
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
Published April 10, 2024 · Recall initiated: February 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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