Recall Z-0795-2016 ยท CAF Nebulizer (Direct Patient Interface)
Pharmacaribe llc
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.
| Date | Feb 10, 2016 (initiated Dec 29, 2015) |
| Status | Terminated |
| Reason | Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) |
| Root cause | Error in labeling |
| Action | PharmaCaribe, together with its Contract Manufacturing firm Asept Pak, Inc., have initiated or completed the following actions to issued an Urgent Notice: Field Notification to Medical Device letter dated January t7, 2016. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Determine what is on hand and what has been distributed. Using the Return Notice provided, report this information as per the instructions on the notice. Please record units as either cases or as cartons (if the cases have been opened and are partial). Thi |
| Quantity | 7,020 vials |
| Distribution | US Nationwide Distribution in the states of FL, LA, TX and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130091 | PULMOSAL Pharmacaribe, Mar 13, 2013 |