FDA Medical Device Recalls (openFDA)
GETINGE US SALES LLC: HEMASHIELD Knitted Double Velour Cardiovascular Fabric
- Recall number
- Z-1172-2018
- Recalling firm
- GETINGE US SALES LLC
- Product
- HEMASHIELD Knitted Double Velour Cardiovascular Fabric
- Status
- Terminated
- Initiated
- 2018-01-03
- Posted
- 2018-03-20
- Terminated
- 2018-07-03
- Reason
- 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
- 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
- 1
- Distribution
- FL
- Lot, serial or model codes
- UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229
- 510(k) numbers
- ["K955349"]
- PMA numbers
- not on file
- Product code
- DXZ
- Firm FEI
- 3012092534
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28