FDA Medical Device Recalls (openFDA)
Halyard Health, Inc: Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
- Recall number
- Z-0119-2018
- Recalling firm
- Halyard Health, Inc
- Product
- Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
- Status
- Terminated
- Initiated
- 2017-10-06
- Posted
- 2017-11-18
- Terminated
- 2020-09-01
- Reason
- Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- Root cause
- Under Investigation by firm
- Action
- Customers were notified via FedEx on 10/06/2017. Instructions included to evaluate and quarantine any affected product in current inventory. For their direct distributors, instructions were to complete and return the response form and also coordinate the return of any affected product. If further distributed, those end users and customers were instructed to destroy any affected product.
- Quantity
- 52,660 kits (2,633 cases) with 631,920 saline vials
- Distribution
- Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
- Lot, serial or model codes
- Product Code 22106 with Lots AB6011U20, AB6123U07 AB6123U01, AB3207U04, AB6284U17; Product Code 221036 with Lot AB6263U11; Product Code 22108147 with Lots AB6011U15, AB6067U17, AB6256U13
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSY
- Firm FEI
- 3011270181
- Firm city
- Alpharetta
- Firm state
- GA
- 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