Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F
FDA device recall Z-1111-05 · posted 2005-08-10 · Terminated
Recall details
- Recalling firm
- Medtronic Neurosurgery
- Reason for recall
- Cracked hubs/handles and/or improper peeling of the sheath during use.
- Action taken
- Firm sent recall letters by Fedex on July 5, 2005 to all customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWG
- Quantity affected
- 79
- Distribution
- Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom.
- Date initiated
- 2005-07-05
- Date posted
- 2005-08-10
- Date terminated
- 2008-06-26
- Location
- Goleta, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 (K990333) | Medtronic PS Medical | 1999-04-28 |