Z-0403-2022Class II

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

Name: Z-0403-2022 Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Creator: Maquet Cardiovascular, LLC
Published: 2021-12-01
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2021-12-01 / Terminated / root cause: labeling and UDI

FDA source

Maquet Cardiovascular, LLC began a recall of Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 on 2021-12-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0403-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-01
Posted: 2021-12-20
Terminated: 2024-02-28
Recalling firm: Maquet Cardiovascular LLC
Product: Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Product code: MAL Graft, Vascular, Synthetic/Biologic Composite
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.
Root cause tag: labeling and UDI
FDA root cause: 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 [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0403-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0403-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-20

Product code MAL

K954848Class IIHemashield Microvel Velour Knitted Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. / cleared 1996-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)