Recall Z-2781-2017 ยท DYB Introducer, Catheter
Greatbatch Medical
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
| Date | Nov 11, 2016 |
| Status | Terminated |
| Reason | Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use. |
| Root cause | Process control |
| Action | Consignee was sent via email on 11/11/2016 a Greatbatch "Urgent Medical Device Recall" letter dated November 2016. The letter described the product involved in the recall, Reason for Field Corrective Action, Risk to Health, Replacement Devices & Instructions to Customer. Advised consignees to quarantine the product, contact end users & complete and return the Field Recall Response Form to Stericycle at Greatbatch7893@stericycle.com or fax at 888-473-8015. For questions contact your local Greatbatch Medical representative, contact us at 1-763-951-8235, or e-mail us at FieldActionCenter@Grea |
| Quantity | 5,000 devices |
| Distribution | NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072248 | VIAPEEL PEELABLE INTRODUCER Enpath Medical, Inc., Nov 9, 2007 |