Z-0795-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2016
- Initiation Date
- December 29, 2015
- Termination Date
- March 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,020 vials
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+)
Distribution Pattern
US Nationwide Distribution in the states of FL, LA, TX and VA
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)