ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
This recall has been terminated (originally issued November 11, 2016).
- Company
- Greatbatch Medical
- Recall Initiated
- November 11, 2016
- Terminated
- November 3, 2017
- Recall Number
- Z-2781-2017
- Quantity
- 5,000 devices
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
Distribution
NY
Lot / Code Info
Lot Number: W3101005
Root Cause
Process control
Action Taken
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@Greatbatch.com