Z-2277-2024 Class II Ongoing
FDA device recall Z-2277-2024 was initiated by American Contract Systems Inc on May 15, 2024 and is designated Class II. Reason for recall: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. The recall status is ongoing. Affected quantity: 48 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 17, 2024
- Initiation Date
- May 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 units
Product Description
LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
Reason for Recall
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 00191072214553 LOT#"s: 943241
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2277-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026