Arrow Arterial, CVC, Epidural, PSI, & MAC Kits
EIF 000606
Recalls, Market Withdrawals & Safety Alerts
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Overview:
Notice from Ferndale Laboratories, Inc. (refer to Attachment 1). As such Arrow International LLC, are initiating a voluntary recall for the above listed products. Teleflex placed impacted Ferndale MASTISOL® Liquid Adhesive components into the product referenced above.
Refer to Appendix 2 for Product Code, Lot Number and Unique Device Identifier (UDI) information.
Description of the Issue:
Risk Assessment:
Action Required: Refer to the Field Safety Notice.
Adverse Reactions / Quality Problems: Adverse reactions or quality problems experienced with the use of this product should be reported to the Teleflex Customer Service at the contact information available in the Field Safety Notice.
Transmission of this Safety Notice: This notice should be passed on to all persons who need to be aware within your organization or to any organization where the potentially affected devices has been transferred. Please consider end users, clinicians, risk managers, supply chain/distribution centers, etc, in the circulation of this notice. Please maintain awareness of this notice until all required actions have been completed in your organization.
Contact Information: Should you require any further information or support concerning this issue, please contact recalls@teleflex.com.