Recall Z-1111-05 ยท GWG Endoscope, Neurological
Medtronic Neurosurgery
Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F
| Date | Aug 10, 2005 (initiated Jul 5, 2005) |
| Status | Terminated |
| Reason | Cracked hubs/handles and/or improper peeling of the sheath during use. |
| Root cause | Other |
| Action | Firm sent recall letters by Fedex on July 5, 2005 to all customers. |
| Quantity | 79 |
| Distribution | Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990333 | MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 Medtronic PS Medical, Apr 28, 1999 |