Arrow
EIF 000608
Recalls, Market Withdrawals & Safety Alerts
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Overview:
Arrow International LLC, a subsidiary of Teleflex Incorporated, is initiating a voluntary field correction for certain Arrow® Kits and Sets that contain Lidocaine and Bupivacaine.
Refer to Appendix 2 for Product Code and Lot Number information to identify the Arrow Kits and Sets within scope for this notice. Refer to the QRCode or FSN portal link, above, to view Product Code, Lot Number, and Unique Device Identifier (UDI) information electronically.
Description of the Issue:
Our supplier Huons Co. Ltd. and its distributor, Spectra Medical Devices Inc, have notified Teleflex of a voluntary recall of all lots of Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP due to quality issues identified during a recent FDA inspection of Huons and limited reports of drug ineffectiveness.
Use of Lidocaine and Bupivacaine product with reduced anesthetic effectiveness, may result in ineffective pain control, procedural discomfort, or repeat or delayed treatment.
Arrow Kits & Sets in scope of this notice are not being removed; you may continue to use the other products in the Arrow kits and sets in scope of this notice, consistent with the instructions included in the notice to destroy the affected Lidocaine or Bupivacaine (see Figure 1 and Table 1 for impacted medications) at the point of use.
Risk Assessment:
As of 15-APR-2026, Teleflex has received a total of 15 complaints, for products in scope of this Field Safety Notice, in which users indicated ineffective pain control.
Required Immediate Actions for Users:
- Ensure all relevant personnel in your organization are informed of this notice.
- Do not use the affected Lidocaine or Bupivacaine vials included in affected Arrow kits in scope of this notice.
- At the point of use, upon opening the kit, discard the affected Lidocaine or Bupivacaine vials in accordance with your facility’s procedures.
- Obtain Lidocaine or Bupivacaine separately through your facility pharmacy and prepare / administer it per institutional protocols prior to the procedure.
In addition to placing a copy of this notice with affected product, if customers wish to further distinguish affected product in their inventory, alert sticker files are available at the following link for download and printing.
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.