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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 84
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.
Part of a larger recall action
This product is one of 39 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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