Sklar Instruments: Device Recall

Recall #Z-0954-2025 · 12/03/2024

Class II: Risk

Recall Details

Recall Number
Z-0954-2025
Classification
Class II
Product Type
Device
Recalling Firm
Sklar Instruments
Status
Ongoing
Date Initiated
12/03/2024
Location
West Chester, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41850 units

Reason for Recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Product Description

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25, Model Number 96-2356A; 5) ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25, Model Number 96-2358A; 6) ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25, Model Number 96-2417; 7) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50, Model Number 96-2580; 8) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581; 9) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581A; 10) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583; 11) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583A; 12) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585; 13) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585A; 14) ECONO STERILE WEBSTER NH SMO 5.25" STER CS50, Model Number 96-2586; 15) ECONO STERILE WEBSTER NH SMO 5.25" STER CS25, Model Number 96-2587; 16) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/50, Model Number 96-2590; 17) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591; 18) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591A; 19) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/50, Model Number 96-2594; 20) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595; 21) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595A; 22) ECONO STERILE MAYO-HEGAR NH 5" STERILE CS/25, Model Number 96-2599; 23) ECONO STERILE WEBSTER NH SMO 5 1/4 STRL C100, Model Number 96-2659; 24) ECONO STERILE MAYO-HEGAR NH 7" STERILE CS/50, Model Number 96-2710; 25) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711; 26) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711A; 27) ECONO STERILE MAYO-HEGAR NH 8" STERILE CS/50, Model Number 96-2712; 28) ECONO STERILE WEBSTER NH FINE 5.25" STER 25, Model Number 96-2740A; 29) ECONO STERILE WEBSTER NH X-FIN LG 5" STER 25, Model Number 96-2741A; 30) ECONO STERILE WEBSTER NH X-FN SMO 5" STER 25, Model Number 96-2742A; 31) ECONO STERILE HALSEY NH SERR TC 5" STER CS25, Model Number 96-2745A; general orthopedic surgery

Distribution Pattern

Domestic: Nationwide Distribution

Other Recalls by Sklar Instruments

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.