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U.S. Department of Health and Human Services

Class 2 Device Recall Hemashield Gold Knitted Bifurcated

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  Class 2 Device Recall Hemashield Gold Knitted Bifurcated see related information
Date Initiated by Firm December 01, 2021
Create Date December 20, 2021
Recall Status1 Terminated 3 on February 28, 2024
Recall Number Z-0403-2022
Recall Event ID 89119
510(K)Number K954848  
Product Classification Graft, vascular, synthetic/biologic composite - Product Code MAL
Product Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Code Information Lot number: 20C04; Serial Numbers: 1260004700 and 1259882880; UDI Code: (01)00384401017752(11)200304(17)250228(21)1260004700GS(10)20C04 (01)00384401017752(11)200304(17)250228(21)1259882880GS(10)20C04
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
Manufacturer Reason
for Recall		 There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.
FDA Determined
Cause 2		 Labeling Change Control
Action And URGENT MEDICAL DEVICE REMOVAL notification letter dated 12/1/21 was sent to customers. Actions to be taken: " If you have already implanted one of the above-mentioned devices, kindly notify us as soon as possible by contacting your Getinge representative or Customer Service (at 1-888-943-8872, options 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. You will be contacted shortly by our Medical Affairs Officer in order to discuss the appropriate follow up. " Please examine your inventory immediately to determine if you one of the Hemashield Gold Knitted Bifurcated Vascular Graft with a Serial Number matching those listed on page 1 of this letter. " Should you have un-used affected product, you are eligible for credit or a replacement at no cost to your facility upon receipt of Response Form (see page 4). " To get your free replacement Graft we need you to provide a ship to contact and your acknowledgment on page 4. " Please contact Getinge Customer Service at 1-888-943-8872, (press option 2) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request shipping instructions to return any affected product. " Pack the product to be returned with the appropriate return documents. " Whether you have affected product or not, please complete and sign the attached URGENT MEDICAL DEVICE REMOVAL RESPONSE FORM (page 4) to acknowledge this recall and return the completed form to Getinge by e-mailing a scanned copy to Hemashield.Intervascular@getinge.com or by FAX to 877-258-1332. " Please forward this information to all current and potential Hemashield Gold Knitted Microvel double velour vascular graft users within your hopsital / facility. " If you are a distrubutor who has shipped any affected product to customers, please forward this document to their attention for appropriate action. This voluntary recall only affects the product with the serial number and lot number listed on page 1; no other products
Quantity in Commerce 2
Distribution US Nationwide distribution in the states of IL and NC.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAL and Original Applicant = MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
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