FDA Medical Device Recalls (openFDA)
Abbott: Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
- Recall number
- Z-0420-2022
- Recalling firm
- Abbott
- Product
- Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
- Status
- Terminated
- Initiated
- 2021-11-16
- Posted
- not on file
- Terminated
- 2024-06-18
- Reason
- As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
- Root cause
- Under Investigation by firm
- Action
- The firm initiated the recall by telephone on 16 NOV 2021 followed by a letter emailed on 18 NOV 2021. The letter explained the problem and requested the return of the affected devices.
- Quantity
- 10 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
- Lot, serial or model codes
- Model 407831, Lot 7748246, GTIN: 15414734008805
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3005334138
- Firm city
- Plymouth
- Firm state
- MN
- 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