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Recall Observatory FDA recall evidence

Device product

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC

Z-1980-2018

April 11, 2018

Class II

Product summary

Firm
Arrow International Inc
Event
Event 79890
Status
Terminated
Classification
Class II
Quantity
416,055 total products
Official record key
device-enforcement:Z-1980-2018

Official wording

Reason: Product sterility may be compromised due to unsealed packaging.

Code information: Lot Numbers: 13F17A0285 13F17C0381 13F17D0214 13F17E0356 13F17F0736 13F17H0483

Distribution pattern: US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    unsealed packaging
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility may be compromised