PharmaCaribe PulmoSal 7% Sodium chloride — Class II medical device recall Z-0795-2016
Terminated recall by Pharmacaribe llc, reported 2016-02-17, distributed nationwide. Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
| Recall number | Z-0795-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmacaribe llc, Punta Gorda, FL, United States |
| Recall initiated | 2015-12-29 |
| Classified | 2016-02-10 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2017-03-28 |
| Distributed | Nationwide (US) |
| Quantity | 7,020 vials |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00030915339988, 10030915339985 |
| Expiration dates | 2017-08-20 |
Product
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.
Reason for recall
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
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-0795-2016. 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.