Z-0795-2016Class II

PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic...

Name: Z-0795-2016 PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic...
Creator: Pharmacaribe llc
Published: 2015-12-29
License: https://open.fda.gov/license/

Pharmacaribe LLC / initiated 2015-12-29 / Terminated / root cause: labeling and UDI

FDA source

Pharmacaribe llc began a recall of PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The... on 2015-12-29. FDA classified it as Class II and gives the reason as "Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0795-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-29
Posted: 2016-02-10
Terminated: 2017-03-28
Recalling firm: Pharmacaribe LLC
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.
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
Root cause tag: labeling and UDI
FDA 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). 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: [email protected]
Quantity in commerce: 7,020 vials
Distribution: US Nationwide Distribution in the states of FL, LA, TX and VA
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0795-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0795-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-10

Product code CAF

K130091Class IIPulmosalPharmacaribe / cleared 2013-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)