| Class 1 Device Recall Sterile Water for Inhalation | |
Date Initiated by Firm | September 05, 2017 |
Date Posted | February 04, 2019 |
Recall Status1 |
Terminated 3 on April 16, 2024 |
Recall Number | Z-0714-2019 |
Recall Event ID |
81021 |
Product Classification |
Nebulizer (direct patient interface) - Product Code CAF
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Product | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt. |
Code Information |
Model # 0352IMJ Lot Numbers: ¿A457, A597, B157, B236, Z589, Z655, Z656, and Z661 |
Recalling Firm/ Manufacturer |
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company 330 Corporate Woods Pkwy Vernon Hills IL 60061-3107
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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 | 128,000 sold to Japan only |
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, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland. |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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