ATTACHMENT H_CERTIFICATION OF RECALL OR SAFETY ISSUES.docx

This is a Certification of Recall or Safety Issues form required as part of the solicitation response for NX EQ Laparoscopic Insufflators (Solicitation Number 36C10X26R0009). The Department of Veterans Affairs Strategic Acquisition Center Frederick is procuring new OEM laparoscopic insufflators under a set-aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns. Offerors must complete and sign this certification form, providing their Company Unique Entity Identifier (UEI) and certifying that the proposed medical equipment has no outstanding recalls, no known safety issues, complies with all relevant regulations and standards for medical equipment, and has been thoroughly checked for compliance with safety and performance standards. The certification must be signed by an authorized representative of the company and submitted with the offer.

The form serves as a critical compliance document, as false or misleading information provided in the certification may result in disqualification from the solicitation process and other penalties as permitted by law. Offerors are instructed to complete all fields and ensure an authorized company representative signs the form prior to submission. This attachment is part of a broader solicitation that requires only new OEM equipment with FOB Destination delivery terms, with specific delivery locations and dates to be identified in individual orders issued under the resulting contract.