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Recall Observatory FDA recall evidence

Device product

Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.

Z-1228-2017

January 11, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 76237
Status
Terminated
Classification
Class II
Quantity
215,703 units
Official record key
device-enforcement:Z-1228-2017

Official wording

Reason: There have been complaints for peel away sheaths flaring

Code information: Material # ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01552-LS, PI-01552-LS5, PI-01552-SS, PL-05041, PL-05041, PL-05052, PR-05041, PR-05041, PR-05041-T, PR-05042, ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01351-SS, PI-01451-LS, PI-01451-LS5, PI-01451-SS, PI-01451-SS, PI-0-1552-LS

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There have been complaints for peel away sheaths flaring