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Recall Observatory FDA recall evidence

Device product

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access

Z-0053-2020

May 17, 2019

Class II

Product summary

Firm
Arrow International Inc
Event
Event 82984
Status
Terminated
Classification
Class II
Quantity
3,143
Official record key
device-enforcement:Z-0053-2020

Official wording

Reason: Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.

Code information: Lot/Batch Numbers: 13F18C0374, 13F18H0580, 13F18D0504, 13F18L0507, 13F18E0380, 13F18L0714, 13F18G0180, 13F18L0936, 13F18G0480

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling error