Halyard Closed Suction System for Adults — Class II medical device recall Z-0119-2018
Terminated recall by Halyard Health, Inc, reported 2017-11-29, distributed in AL, AZ, CA, CO, DE, FL, GA, HI…. Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking
| Recall number | Z-0119-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Halyard Health, Inc, Alpharetta, GA, United States |
| Recall initiated | 2017-10-06 |
| Classified | 2017-11-18 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2020-09-01 |
| Distributed | 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 |
| Reason classes | packaging |
| Lot numbers | AB3207U04, AB6011U15, AB6011U20, AB6067U17, AB6123U01, AB6123U07, AB6256U13, AB6263U11, AB6284U17 |
Product
Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0119-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.