Normal Saline Flush 0 — Class I medical device recall Z-0926-2017
Terminated recall by Nurse Assist, Inc, reported 2017-01-11, distributed nationwide. Potential contamination with B. cepacia.
| Recall number | Z-0926-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nurse Assist, Inc, Haltom City, TX, United States |
| Recall initiated | 2016-10-04 |
| Classified | 2017-01-03 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2017-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 386,175 syringes |
| Pathogens | burkholderia |
| Model numbers | 1203, 1205, 1210, 1210-BP, 1509282, 1511001, 1511075, 1511328, 1511329, 1512048, 1512053, 1512072, 1601355, 1602028, 1602048, 1602137, 1602178, 1603029, 1603060, 1604273, 1604431, 1604432, 1604433, 1605387, 1606076 and 4 more |
Product
Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush
Reason for recall
Potential contamination with B. cepacia.
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-0926-2017. 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.