FDAClass IISeptember 21, 2016

Cather recall

Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

Why was Cather recalled?

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

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: 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

Product
Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
Recalling firm
Arrow International Inc
Quantity
6,121 units in total
Distribution
US Distribution to states of: NC, OH, FL, and MD.
Recall date
September 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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