Arthroscopy Procedure Tray Recalled for Excess Sterilization Residue
American Contract Systems recalls the ARTHROSCOPY WOLFSON PACK BHS Procedure tray because ethylene oxide residuals on the cast padding exceeded safety limits for permanent exposure medical devices.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall. No illnesses or injuries reported. The contaminated surgical instruments represent risk-of-harm products where injury has not yet been reported, meeting the severity rubric criteria for score 3.
Plain-English summary
American Contract Systems Inc is recalling the ARTHROSCOPY WOLFSON PACK BHS Procedure tray (Catalog Number BPAR65A) distributed nationwide in the United States. Approximately 96 units were affected.
The cast padding component of the procedure tray contains ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals that exceed the approved residual limits for permanent exposure devices, as specified in ANSI/AAMI/ISO 10993-7/(R)2012 standards. These residuals are byproducts of the sterilization process.
This tray is used in arthroscopic surgical procedures. Healthcare facilities and surgical centers that received the affected lot numbers should stop using these trays immediately.
No illnesses or injuries have been reported. Users of affected lot numbers (661231, 971241, 928241, or 893241) should contact American Contract Systems Inc for instructions on returning or replacing the recalled procedure trays. The device UDI-DI is 00191072187444.
The recalled product
- Product
- ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide
- sterilization-residue
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00191072187444 LOT#"s: 661231 971241 928241 893241
Distribution
Distributed nationwide across the United States.
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