FDAClass IIAugust 26, 2020

ClosureFast Micro Introducer Sheath Set recall

ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone…

Why was ClosureFast Micro Introducer Sheath Set recalled?

Sterile introducer sheath set manufactured under one lot with different expiration dates.

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 11295042

Product
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone…
Recalling firm
Argon Medical Devices, Inc
Quantity
1000 units
Distribution
US Nationwide distribution including in the state of MS.
Recall date
August 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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