Recalls / —
—#143987
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.
- FDA product code
- DRE — Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K780126
- Affected lot / code info
- Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)
Why it was 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.
Root cause (FDA determination)
Process control
Action the firm took
On February 17, a letter was sent to Medtronic notifying them of a voluntary recall.
Recalling firm
- Firm
- Argon Medical Devices, Inc
- Address
- 1445 Flat Creek Rd, Athens, Texas 75751-5002
Distribution
- Distribution pattern
- Distributed in IL.
Timeline
- Recall initiated
- 2016-02-17
- Posted by FDA
- 2016-03-01
- Terminated
- 2017-03-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #143987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.