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U.S. Department of Health and Human Services

Class 2 Device Recall PulmoSal

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  Class 2 Device Recall PulmoSal see related information
Date Initiated by Firm December 29, 2015
Date Posted February 10, 2016
Recall Status1 Terminated 3 on March 28, 2017
Recall Number Z-0795-2016
Recall Event ID 73053
510(K)Number K130091  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
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.
Code Information 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)
Recalling Firm/
Pharmacaribe llc
3513 Dileuca St
Punta Gorda FL 33950-7835
For Additional Information Contact Lisa Early
Manufacturer Reason
for Recall
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
FDA Determined
Cause 2
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). This document is to be returned via mail or email as per the guidance provided. This will inform the Manufacturer of your inventory status and of your intentions regarding product replacement. Cases of this product may be returned for new cases of the same product (different lot) that have the correct embossing on the vials. Instructions for return are provided in the Field Notification Package Cover Letter. Alternatively, customers may choose to be issued a full refund for all returned product. For cases which have already been distributed to the retail/clinician level and/or are in use by patients, it is acceptable to continue to use the product, with the understanding (and proper communication to all parties) that the tabs on the vials are incorrectly labeled. Contact information: Lisa Early, QA Manager Asept Pak, Inc. Phone: 518-651-2026 Fax: 518-651-2046 E-mail: learly@aseptpak.com
Quantity in Commerce 7,020 vials
Distribution US Nationwide Distribution in the states of FL, LA, TX and VA
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAF and Original Applicant = PHARMACARIBE