ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS...
FDA Recall #Z-0929-2025 — Class II — December 3, 2024
Product Description
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A; 4) ECONO STERILE WEITLANER RETR SH 3X4 5.5"CS25, Model Numbers: 96-2208A; 5) ECONO STERILE WEITLANER RETR 3X4 SH 8" CS/10, Model Numbers: 96-2209A; 6) ECONO STERILE WEITLANER RETR 3X4 BL 8" CS/10 , Model Numbers: 96-2210A; 7) ECONO STERILE HOLZHEIMER RETR 4PRG SH 4"CS25, Model Numbers: 96-2241A; 8) ECONO STERILE HOLZHEIMER RETR 4PRG BL 4"CS25, Model Numbers: 96-2242A; surgical retractor
Reason for Recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Recalling Firm
Sklar Instruments — West Chester, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
75 units
Distribution
Domestic: Nationwide Distribution
Code Information
1) 96-2201A, UDI/DI 50649111493100, Lot Codes: SK-120; 2) 96-2203A, UDI/DI 50649111493094, Lot Codes: SK-120; 3) 96-2207A, UDI/DI 50649111493117, Lot Codes: SK-120; 4) 96-2208A, UDI/DI 50649111493124, Lot Codes: SK-120 5) 96-2209A, UDI/DI 50649111493155, Lot Codes: SK-120; 6) 96-2210A, UDI/DI 50649111493162, Lot Codes: SK-130; 7) 96-2241A, UDI/DI 50649111492820, Lot Codes: SK-115; 8) 96-2242A, UDI/DI 50649111492837, Lot Codes: SK-115;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.