Z-1172-2018Class II

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

Name: Z-1172-2018 HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Creator: Getinge US Sales Llc
Published: 2018-01-03
License: https://open.fda.gov/license/

Getinge US Sales LLC / initiated 2018-01-03 / Terminated / root cause: labeling and UDI

FDA source

GETINGE US SALES LLC began a recall of HEMASHIELD Knitted Double Velour Cardiovascular Fabric on 2018-01-03. FDA classified it as Class II and gives the reason as "A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm...". 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-1172-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-03
Posted: 2018-03-20
Terminated: 2018-07-03
Recalling firm: Getinge US Sales LLC
Product: HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Product code: DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Reason for recall: A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On January 3, 2018 an URGENT MEDICAL DEVICE RECALL NOTICE was issued to the (1) affected customer. A return authorization was issued with the recall letter, which is intended to be returned to the recalling firm. Questions or concerns can be directed to 1-800-528-7486
Quantity in commerce: 1
Distribution: FL
Product codes and lots: UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1172-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1172-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-23

Product code DXZ

K955349Class IIHemashield Knitted Double Velour Cardiovascular FabricMeadox Medicals, Div. Boston Scientific Corp. / cleared 1996-02-14

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)