PlainRecalls
FDA Devices Moderate Class II Ongoing

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 Number

Reported: January 22, 2025 Initiated: December 3, 2024 #Z-0929-2025

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.

Details

Recalling Firm
Sklar Instruments
Units Affected
75 units
Distribution
Domestic: Nationwide Distribution
Location
West Chester, PA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Sklar Instruments. Units affected: 75 units.
Why was this product recalled? ▼
Reports of various packaging issues that may result in a breach of the sterile barrier.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0929-2025.

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