Medical device components subjected to improper sterilization process and elevated exposure
American Contract Systems is recalling LAVH surgical component kits because two components were subjected to improper sterilization temperatures and ethylene oxide exposure, potentially causing loss of functionality and higher chemical residuals.
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 with no reported hospitalizations or injuries. However, potential loss of functionality and higher-than-approved ethylene oxide residuals in surgical components represent a significant risk of harm, meeting the rubric criterion for High: "risk-of-harm products where injury has not yet been reported."
Plain-English summary
American Contract Systems, Inc. is recalling the LAVH (laparoscopic-assisted vaginal hysterectomy) kit, model REF BBLV21C (UDI/DI 00191072166234, Lot Number 686221), distributed nationwide in Florida and Iowa. The recall involves 18 cases of this surgical component kit.
The recall was initiated after an internal investigation discovered that two components—an I.V. Catheter (part number 4252535-02) and Adhesive Dermabond (part number DHVM12)—were subjected to the company's sterilization process using ethylene oxide (EO) at temperatures higher than those approved by the component manufacturers. This exposure may result in loss or lack of component functionality, potential loss of drug efficacy, and higher than specified ethylene oxide residuals remaining in the components.
Healthcare facilities and clinicians who have received these kits should not use them and should contact American Contract Systems, Inc. for instructions on returning or destroying the affected product. Patients who have received treatment with potentially affected components should consult their healthcare provider if they experience any unusual symptoms or complications.
The recalled product
- Product
- LAVH, REF BBLV21C
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- improper-sterilization
- eo-residual
- loss-of-functionality
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 (2)
- UDI/DI 00191072166234
- Lot Number 686221
Distribution
Distributed nationwide across the United States.
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