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Recall Observatory FDA recall evidence

Device product

Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1

Z-1988-2018

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-1988-2018

Official wording

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

Code information: Lot Numbers: Product Code ASK-42703-PAM1: 13F17K0077 13F17L0494 Product code ASK-42703-PSHR1: 13F17C0361 13F17F0207 13F17H0518 13F17M0278 Product code ASK-45703-PNY: 13F17H0124 13F17H0451 Product code ASK-45703-PWHC1: 13F17E0022

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