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Class 1 Device Recall Sterile Water for Inhalation |
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Date Initiated by Firm |
September 05, 2017 |
Date Posted |
February 04, 2019 |
Recall Status1 |
Terminated 3 on April 16, 2024 |
Recall Number |
Z-0721-2019 |
Recall Event ID |
81021 |
510(K)Number |
K820227
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Product Classification |
Nebulizer (direct patient interface) - Product Code CAF
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Product |
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿
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Code Information |
Model # UD9005 Lot Number: ¿B515 |
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
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Manufacturer Reason for Recall |
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
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FDA Determined Cause 2 |
Process control |
Action |
Firm sent recall notification letters to customers on 9/5/2017. |
Quantity in Commerce |
106,000 |
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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510(K) Database |
510(K)s with Product Code = CAF and Original Applicant = INHALATION THERAPY EQUIPMENT, CO.
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