Arthroscopy Pack Recalled for Excessive Sterilization Chemical Residue
American Contract Systems is recalling 345 units of the AHAR50K Standard Arthroscopy Pack due to ethylene oxide residue levels exceeding regulatory limits. Affected lot numbers are 638231, 962241, and 898241.
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 of a surgical device with documented chemical residue exceeding regulatory limits. This is a risk-of-harm product involving direct tissue contact, but no illnesses or injuries have been reported in the source text, placing it at the High severity tier.
Plain-English summary
American Contract Systems Inc is recalling 345 units of the AHAR50K Standard Arthroscopy Pack procedure trays distributed nationwide in the United States. The pack is used in arthroscopic surgical procedures.
The recall was issued because ethylene oxide and ethylene chlorohydrin (EO/ECH) residual levels on the cast padding component exceeded the permitted limits for permanent exposure devices as specified by the ANSI/AAMI/ISO 10993-7(R)2012 standard. Sterilization residue at levels above regulatory limits may pose a health risk to patients during arthroscopic procedures.
The affected lot numbers are 638231, 962241, and 898241, identified by UDI-DI 00191072214126. Healthcare providers and surgical facilities should verify their inventory against these lot numbers and follow appropriate recall procedures for affected units.
The recalled product
- Product
- AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-residue
- ethylene-oxide
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: 00191072214126 LOT#"s: 638231 962241 898241
Distribution
Distributed nationwide across the United States.
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