FDA Device recall Z-0120-2018
Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 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, 14 F, Elbow, Directional Tip, Wet Pak. 12 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-0120-2018 |
| 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, 14 F, Elbow, Directional Tip, Wet Pak. 12 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 22169, Lots AB6123U08, AB6123U11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0120-2018%22
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