Pharmacaribe llc: Medical Device Recall in 2016 - (Recall #: Z-0795-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 29, 2015

Date Posted: February 17, 2016

Recall Number: Z-0795-2016

Event ID: 73053

Reason for Recall:

Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)

Status: Terminated

Product Quantity: 7,020 vials

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)

Distribution Pattern:

US Nationwide Distribution in the states of FL, LA, TX and VA

Voluntary or Mandated:

Voluntary: Firm initiated