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Recall Observatory FDA recall evidence

Device product

Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿

Z-0710-2019

September 05, 2017

Class I

Product summary

Firm
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Event
Event 81021
Status
Terminated
Classification
Class I
Quantity
70,860
Official record key
device-enforcement:Z-0710-2019

Official wording

Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information: Model # 352 Lot Numbers: A214, A215, Z263, Z532, and Z555

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility