FDA recall Z-1434-2024

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

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-02-23

Report date

2024-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

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