FDA Device recall Z-0795-2016
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx…
- FDA Device
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx… by Pharmacaribe, citing vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0795-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-29 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Pharmacaribe |
| Distribution | US |
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
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
Identifiers
| upc | 030915339988 |
|---|---|
| upc | 10030915339985 |
| code_info | Lot # CIY Exp.Date August 2017 UPC Number: 030915339988 (on the box of 60 vials) UPC Number: 10030915339985 (on the shipping case of 12 boxes) |
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-0795-2016%22
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