Knee Arthroscopy Pack Recalled for Excess Sterilization Residues
American Contract Systems Inc. is recalling 84 knee arthroscopy packs (Catalog Number MEKA12R) distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe 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: This is an FDA Class II medical device recall. Although no illnesses or injuries have been reported, the product involves permanent exposure in surgical settings, making it a risk-of-harm product. The chemical residuals exceed established safety standards for such permanent-contact devices.
Plain-English summary
American Contract Systems Inc. is recalling 84 knee arthroscopy packs (Catalog Number MEKA12R, Lot Numbers 659231 and 978241) that were distributed nationwide.
The packs are recalled because ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals in the cast padding component exceeded the permissible limits for permanent exposure medical devices under ANSI/AAMI/ISO 10993-7/(R)2012.
Ethylene oxide and ethylene chlorohydrin are sterilization agents. Residual levels of these chemicals in the finished product can pose health risks if they exceed the safety standards established for devices in direct contact with patients during surgical procedures.
The recalled product
- Product
- KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Surgical pack
- Hazard
- ethylene-oxide-residue
- sterilant-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: 00191072174475 LOT#"s: 659231 978241
Distribution
Distributed nationwide across the United States.
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