FDA Device recall Z-0117-2018
Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case
- FDA Device
- Class II
- terminated
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case by Halyard Health, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0117-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-06 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Halyard Health |
| Distribution | 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 |
Product
Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.
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.
Identifiers
| code_info | Product Code 2216 with Lot AB6032U03; Product Code 22056 with Lot AB6032U12; Product Code 220569 with Lot AB6207U11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Halyard Health
- Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults
FDA Device · Class II · 2018-04-25 · Halyard Health - Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway
FDA Device · Class II · 2018-04-25 · Halyard Health - Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liq…
FDA Device · Class II · 2018-04-25 · Halyard Health - CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI…
FDA Device · Class II · 2018-04-11 · Halyard Health - NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 k…
FDA Device · Class II · 2017-11-29 · Halyard Health
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.