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Recall Observatory FDA recall evidence

Device product

Echogenic Needle; Product codes: PN-00215-E and PN-00217-E

Z-2022-2018

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-2022-2018

Official wording

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

Code information: Lot Numbers: Product Codes PN-00215-E: 13F17J0072 13F17K0211 13F17L0700 Product code PN-00217-E: 13F17C0329 13F17E0118 13F17F0503 13F17G0093 13F17G0534 13F17H0383 13F17L0234

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