Device 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.
Z-0795-2016
Product summary
- Firm
- Pharmacaribe llc
- Event
- Event 73053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,020 vials
- Official record key
device-enforcement:Z-0795-2016
Official wording
Reason: Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
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
Derived failure modes
-
Unknown
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)