Lavh, REF Bblv21c recall
LAVH, REF BBLV21C
Why was Lavh, REF Bblv21c recalled?
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00191072166234, Lot Number 686221
- Product
- LAVH, REF BBLV21C
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 18 cases
- Distribution
- US Nationwide distribution in the states of FL, IA.
- Recall date
- November 1, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)