ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2
FDA device recall Z-1029-2016 · posted 2016-03-01 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- 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.
- Action taken
- On February 17, a letter was sent to Medtronic notifying them of a voluntary recall.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DRE
- Quantity affected
- 2000 units
- Distribution
- Distributed in IL.
- Date initiated
- 2016-02-17
- Date posted
- 2016-03-01
- Date terminated
- 2017-03-08
- Location
- Athens, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DILATOR, VESSEL & INTRODUCER, SHEATH (K780126) | Argon Medical Corp. | 1978-03-02 |