Knee Arthroscopy Kit Recalled for Excessive Sterilant Chemical Residue
American Contract Systems Inc is recalling 270 units of a knee arthroscopy surgical kit because sterilization chemical residues exceed safe limits for permanent device contact.
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 recall for a medical device with chemical residuals exceeding established safety limits. No illnesses or injuries have been reported. The hazard represents a risk-of-harm scenario from sterilant residue without yet-reported injury, which per the rubric warrants a High severity score.
Plain-English summary
American Contract Systems Inc is recalling the KNEE ARTHROSCOPY PACK-Procedure Kit (Catalog Number SFAR60A) for use in knee arthroscopic surgical procedures. A total of 270 units have been distributed nationwide in the United States.
The recall was issued because residual levels of ethylene oxide and ethylene chlorohydrin (EO/ECH) on the cast padding component exceeded established safety limits for permanent-contact medical devices, as specified in the ANSI/AAMI/ISO 10993-7 standard for biocompatibility testing. Ethylene oxide is a sterilant gas used in medical device sterilization; residuals that exceed safe exposure limits present a potential hazard to patients.
Affected lots 992241 and 954241 should not be used. Healthcare facilities and individuals in possession of this product are advised to contact American Contract Systems Inc for instructions on safe return or replacement.
The recalled product
- Product
- KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide-residue
- chemical-exposure
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: 00191072167408 LOT#"s: 992241 954241
Distribution
Distributed nationwide across the United States.
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