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Recall Observatory FDA recall evidence

Device product

ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM

Z-2023-2018

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-2023-2018

Official wording

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

Code information: Lot Numbers: Product Code PR-34052-HPHNM: 13F17C0351 Product Code PR-34063-HPHNM: 13F17F0192 Product Code PR-35041-HPHNM: 13F17B0290 13F17C0231 13F17D0238 13F17F0276 13F17F0577 13F17H0365 13F17J0409 13F17K0490 13F17L0394 13F17L0395 Product Code PR-35052-HPHNM: 13F17B0092 13F17B0256 13F17C0043 13F17D0094 13F17D0239 13F17E0224 13F17F0586 13F17H0354 13F17J0196 13F17K0549 13F17L0474 13F17L0697 13F17M0121 Product Code PR-35541-HPHNL: 13F17F0219 13F17H0523 Product Code PR-35541-HPHNM: 13F17A0110 13F17B0046 13F17B0161 13F17C0353 13F17F0652 Product Code PR-35552-HPHNL: 13F17B0322 13F17J0008 Product Code PR-35552-HPHNM: 13F17B0109 13F17B0318 13F17F0245

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