Recall Z-1029-2016
Argon Medical Devices, Inc · initiated February 17, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Codes / lots: Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)
Reason for recall
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.
FDA-determined cause: Process control
Action taken
On February 17, a letter was sent to Medtronic notifying them of a voluntary recall.
Details
- Recall number
- Z-1029-2016
- Initiated
- February 17, 2016
- Posted by FDA
- March 1, 2016
- Terminated
- March 8, 2017
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Quantity
- 2000 units
- Distribution
- Distributed in IL.
- Recalling firm
- Argon Medical Devices, Inc, Athens, TX