FDA Medical Device Recalls (openFDA)
Cook Inc.: Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
- Recall number
- Z-1780-2019
- Recalling firm
- Cook Inc.
- Product
- Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
- Status
- Terminated
- Initiated
- 2019-05-02
- Posted
- not on file
- Terminated
- 2019-08-23
- Reason
- The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
- Root cause
- Under Investigation by firm
- Action
- Urgent Medical Device Recall notification letters dated 5/2/19 were sent to customers.
- Quantity
- 97
- Distribution
- No distribution in the US. Products were distributed to the following foreign countries: China.
- Lot, serial or model codes
- lot 8373482
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGZ
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- 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