Skip to content
Recall Observatory FDA recall evidence

Device product

Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿

Z-0718-2019

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
235,560
Official record key
device-enforcement:Z-0718-2019

Official wording

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

Code information: Model # HCS00350 Lot Numbers: ¿A055, A056, A057, A058, A103, A176, A455, B530, B531, B532, B533, Z101, Z534, Z553, and Z554

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