Recall Z-0795-2016— Pharmacaribe llc

Name: FDA recall Z-0795-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-29

Class II · Terminated

Class II FDA medical device recall by Pharmacaribe llc, initiated 2015-12-29, terminated 2017-03-28. It names one FDA 510(k) clearance: K130091. 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+).

Recalling firm: Pharmacaribe llc
Classification: Class II
Status: Terminated
Initiated: 2015-12-29
Terminated: 2017-03-28
Firm location: Punta Gorda, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K130091 — PULMOSALPharmacaribe·cleared 2013-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.