Skip to content
Recall Observatory FDA recall evidence

Device product

Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.

Z-2773-2016

February 17, 2016

Class II

Product summary

Firm
Arrow International Inc
Event
Event 74898
Status
Terminated
Classification
Class II
Quantity
6,121 units in total
Official record key
device-enforcement:Z-2773-2016

Official wording

Reason: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Code information: Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

Distribution pattern: US Distribution to states of: NC, OH, FL, and MD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.