FDAClass IIAugust 8, 2018

Percutaneous Sheath Introducer Kit for use with 7 - 7.5 recall

Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The…

Why was Percutaneous Sheath Introducer Kit for use with 7 - 7.5 recalled?

Product contains dry natural rubber latex. Label states Latex Free.

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 Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019

Product
Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The…
Recalling firm
Arrow International Inc
Quantity
60 units
Distribution
Puerto Rico
Recall date
August 8, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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