Laceration Tray Kits Recalled Due to Sterilization Assurance Failure
American Contract Systems Inc recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay patient treatment.
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 recall of medical devices with unconfirmed sterilization assurance, representing a risk-of-harm product without reported illnesses or injuries.
Plain-English summary
American Contract Systems Inc is recalling approximately 690 laceration tray kits with model numbers SGLA07A, SGLA07B-01, SGLA07B-02, and SGLA07B. The recall affects kits distributed nationwide in Ohio.
The manufacturer is unable to confirm that product sterilization assurance requirements were met. According to the recall notice, possible loss or lack of functionality may lead to delay or prolonged treatment.
Healthcare facilities and emergency departments with affected kits should cease use immediately and contact American Contract Systems Inc for return or replacement instructions.
The recalled product
- Product
- LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
- Manufacturer
- American Contract Systems Inc
- Affected units
- 690
Distribution
Part of a larger recall action
This product is one of 32 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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