PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: April 10, 2024 Initiated: February 23, 2024 #Z-1434-2024

Product Description

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

Reason for Recall

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.

Details

Units Affected
760 units
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 760 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1434-2024.