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Recall Observatory FDA recall evidence

Device product

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP

Z-1981-2018

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-1981-2018

Official wording

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

Code information: Lot Numbers: ASK-15703-PVH: 13F17D0024 13F17E0454 13F17G0083 13F17H0048 13F17J0096 13F17K0195 13F17L0138 13F17L0679 ASK-15703-PNYP: 13F17H0123

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