Recalls / —

—#198818

Product

VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W

FDA product code

GEI — Electrosurgical, Cutting & Coagulation & Accessories

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K153194

Affected lot / code info

UDI-DI: 00607567700345; Lot Numbers: 3000274687

Why it was recalled

Some batches of product were not sterilized to their minimum sterilization specification.

Root cause (FDA determination)

Process control

Action the firm took

An Urgent Medical Device Removal notification letter dated 3/3/23 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received the Hemopro lot(s) affected by this recall. Please, note that Distributed Affected Lot Number(s) appear on the device shelf boxes only. Please examine your inventory immediately to determine if you have any of the Hemopro with the product code/lot number(s) listed in this notice. " Should you have any affected product lot(s) as listed in this notification, please stop using and remove the complete device from areas of use. If you have affected product, you are entitled to a credit. You will receive credit upon your acknowledgement that you have affected product for return. " Please forward this information to all current and potential Hemopro and Hemopro 2 users within your hospital / facility. " If you are a distributor who has shipped any affected product(s) to customers, please forward this document to their attention for appropriate action. " Please contact Getinge Customer Service at 888-880-2874 between the hours of 6:00 a.m. and 5:00 p.m. Pacific Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. " Whether you have affected product or not, please complete and sign the attached MEDICAL DEVICE Removal - RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet Cardiovascular, LLC /Getinge by e-mailing a scanned copy to Hemopro2023Sterility.act@getinge.com or by faxing the form to 1-800-385-0294 . We apologize for any inconvenience this recall may cause. If you have any questions, please contact your Maquet Cardiovascular, LLC /Getinge representative or call the Getinge Customer Service at (888)

Recalling firm

Firm

Maquet Cardiovascular, LLC

Address

45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Brazil, China.

Timeline

Recall initiated

2023-03-06

Posted by FDA

2023-04-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #198818. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.