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U.S. Department of Health and Human Services

Class 1 Device Recall Sterile Water for Inhalation

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  Class 1 Device Recall Sterile Water for Inhalation see related information
Date Initiated by Firm September 05, 2017
Create Date February 04, 2019
Recall Status1 Open3, Classified
Recall Number Z-0717-2019
Recall Event ID 81021
Product Classification Nebulizer (direct patient interface) - Product Code CAF
Product Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿

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Code Information Model # HCS00300 Lot Number: ¿Y576     
Recalling Firm/
Manufacturer
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
330 Corporate Woods Pkwy
Vernon Hills IL 60061-3107
For Additional Information Contact Christine Thomas
763-383-3048
Manufacturer Reason
for Recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
FDA Determined
Cause 2
Process control
Action Firm sent recall notification letters to customers on 9/5/2017.
Quantity in Commerce 16,380
Distribution Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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