FDAClass IIOctober 16, 2019

Pediatric Two-Lumen Central Venous Catheterization Kit recall: Labeling Error

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (<…

Why was Pediatric Two-Lumen Central Venous Catheterization Kit recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (<…
Recalling firm
Arrow International Inc
Quantity
3,143
Distribution
US Nationwide Distribution
Recall date
October 16, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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