FDA Medical Device Recalls (openFDA)
Arrow International Inc: NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
- Recall number
- Z-2804-2020
- Recalling firm
- Arrow International Inc
- Product
- NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
- Status
- Terminated
- Initiated
- 2020-07-06
- Posted
- not on file
- Terminated
- 2021-11-05
- Reason
- The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
- Root cause
- Incorrect or no expiration date
- Action
- Arrow sent a customer notification letter dated July 6, 2020. This letter informed customers of the affected product, asked them to check and remove inventory, and complete the response form.
- Quantity
- not on file
- Distribution
- World wide distribution
- Lot, serial or model codes
- Product Code: NRH-15192 Lot #: 13F19H0454
- 510(k) numbers
- ["K020430"]
- PMA numbers
- not on file
- Product code
- NFK
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- 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