ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x recall
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11.…
Why was ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x recalled?
The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.
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 1125585 (MIS-F707) Lot 11126021 (IS-7F11)
- Product
- ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11.…
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 2000 units
- Distribution
- Distributed in IL.
- Recall date
- March 9, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)