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VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System… recallZ-1336-2023 · Maquet Cardiovascular, LLC · initiated Mar 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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 [email protected] 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)

Recall details

Recall number
Z-1336-2023
Status
Open, Classified
Initiated by the company
Mar 6, 2023
Posted by the FDA
Apr 4, 2023
Recalling firm
Maquet Cardiovascular, LLC
Quantity
2300 units
Product code
GEI
FDA submissions
K101274
Distribution
Worldwide distribution - US Nationwide and the countries of Brazil, China.

Product description

VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

Code information (models, lots, serial numbers)

UDI-DI: 00607567700406; Lot Numbers: 3000278401, 3000271148, 3000268643, 3000263026, 3000274504, 3000263925

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K101274 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91764).

Sources and updates

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