FDA Medical Device Recalls (openFDA)
Custom Healthcare Systems, Inc.: CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
- Recall number
- Z-0246-2019
- Recalling firm
- Custom Healthcare Systems, Inc.
- Product
- CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
- Status
- Terminated
- Initiated
- 2018-08-13
- Posted
- not on file
- Terminated
- 2022-08-01
- Reason
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Root cause
- Packaging
- Action
- Custom Healthcare Systems (CHS) initiated recall by phone, email and by certified mail on 8/13/18 and carried out to the end user. Custom Healthcare Systems Inc. notified the customers, they were informed to contact their account to receive the product. Product to be returned and credited.
- Quantity
- 160 units
- Distribution
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- Lot, serial or model codes
- Lot number: 52418 Exp. Date: 5/1/2021
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1121091
- Firm city
- Richmond
- Firm state
- VA
- 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