Surgical Device Kits Recalled Due to Improper Sterilization Process
American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.
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 a Class II FDA recall of surgical devices with improper sterilization due to ethylene oxide concentration exceeding specification. Although no illnesses or injuries have been reported in the source, improper sterilization of surgical instruments creates a direct risk of infection to patients, warranting a High severity classification.
Plain-English summary
American Contract Systems, Inc. is recalling the ACS Arthroscopy Kit (Model LMAR15R, Lot 981221), ACS Knee Kit (Model LWKN46N, Lot 966221), and ACS Hand Pack (Model FHHP63T, Lot 966221). A total of 114 packs are affected.
The recalled products were sterilized with an ethylene oxide concentration higher than the manufacturer's specification. This sterilization process defect may compromise the sterility of the surgical instruments.
The affected products were distributed to Illinois, Missouri, Nebraska, and Texas.
The recalled product
- Product
- 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 114
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 (6)
- 1) ACS Arthroscopy Kit - Model LMAR15R
- Lot 981221
- UDI: 00191072152978 2) ACS Knee Kit - Model LWKN46N
- Lot 966221
- UDI: 00191072150158 3) ACS Hand Pack - Model FHHP63T
- UDI: 00191072149954
Distribution
Part of a larger recall action
This product is one of 5 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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