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U.S. Department of Health and Human Services

Class 2 Device Recall Hemopro 2

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 Class 2 Device Recall Hemopro 2see related information
Date Initiated by FirmDecember 22, 2022
Date PostedJanuary 19, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0995-2023
Recall Event ID 91363
510(K)NumberK101274 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductHemopro 2 with Vasoshield, Model VH-4001
Code Information UDI-DI: 00607567700901; Serial Numbers: 25152107, 25152204, 25152293, 25152463, 25152771, 25153153, 25153273, 25153366, 25153585, 25153847, 25153960, 25154066, 25154880, 25155262, 25155326, 25155785, 25156245, 25156642, 25157016, 25157085, 25157244, 25157700, 25157898, 25158066, 25158152, 25158374, 25158822, 25158965, 25159100, 25159335, 25159572, 25159695, 25159791, 25160255, 25160398, 25160498, 25160712, 25160961, 25161193, 25161423, 25161672, 25162202, 25162407, 25162505, 25163168, 25163281, 25163367, 3000236928, 3000251969
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information ContactMaryanna Krivak
973-709-7483
Manufacturer Reason
for Recall		Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.
FDA Determined
Cause 2		Under Investigation by firm
ActionURGENT MEDICAL DEVICE Removal notification letters dated 12/22/22 were sent to customers. Actions to be taken by the Customer: Our records indicate that you have received the Hemopro 2 with Vasoshield and Vasoshield Syringe from lots affected by this recall. Please, note that Distributed Affected Lot Numbers appear on the device shelf boxes only. Please examine your inventory immediately to determine if you have any of Hemopro 2 with Vasoshield and/or Vasoshield Syringe with the product code/lot numbers listed in this notice. LOT numbers can be found on the product label in the area circled in red. 1. Should you have any affected product lots as listed in this notification, please stop using and remove the complete device from areas of use. Distributed Affected Lot Number can be found on the device package. 2. Should you have un-used affected VH-4001 kits and/or VH-5001 (partial or full packs) you are eligible for credit. 3. Please forward this information to all current and potential Hemopro 2 with Vasoshield and Vasoshield Syringe users within your hospital / facility. 4. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. 5. 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. 6. 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 Vasoshield2022.act@getinge.com or by faxing the form to (877)-804-2316. 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 Geting
Quantity in Commerce9817 devices
DistributionUS Nationwide. Japan, Germany.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEI
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