Recall Z-0933-2025— Sklar Instruments
Class II · Ongoing
Class II FDA medical device recall by Sklar Instruments, initiated 2024-12-03. FDA's recall record names no specific 510(k) clearance for this event. Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors. Reason: Reports of various packaging issues that may result in a breach of the sterile barrier..
- Recalling firm
- Sklar Instruments
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-03
- Firm location
- West Chester, PA, United States
Product description
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors
Reason for recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.