—#197573

Product

Hemopro 2 with Vasoshield, Model VH-4001

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K101274
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

URGENT 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

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: US Nationwide. Japan, Germany.

Timeline

Recall initiated: 2022-12-22
Posted by FDA: 2023-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.