Hemashield recallZ-1172-2018 · Getinge US Sales LLC · initiated Jan 3, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Getinge US Sales LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Labeling mix-ups
What the company is doing
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
Recall details
- Recall number
- Z-1172-2018
- Status
- Terminated
- Initiated by the company
- Jan 3, 2018
- Posted by the FDA
- Mar 20, 2018
- Recalling firm
- Getinge US Sales LLC
- Quantity
- 1
- Product code
- DXZ
- FDA submissions
- K955349
- Distribution
- FL
Product description
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Code information (models, lots, serial numbers)
UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Hemashield M002000195140Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 recall2 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K955349 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Hemashield M002000196240Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene10 reports
- Hemashield M002000196270Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2 reports
- Hemashield M002000195290Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 report
- Hemashield M002000195090Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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