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Recall Observatory FDA recall evidence

Device product

ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.

Z-0602-2018

July 25, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 78964
Status
Terminated
Classification
Class II
Quantity
2691 total
Official record key
device-enforcement:Z-0602-2018

Official wording

Reason: Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.

Code information: Lot/Batch Numbers: 13F16A0089, 13F16A0180, 13F17B0290, 23F16F0614.

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.