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Terminated

ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

FDA Recall Z-2781-2017 · Posted None

Recalling FirmGreatbatch Medical
Recall StatusTerminated
Product CodeDYB
Date Initiated2016-11-11
Date Terminated2017-11-03
Product Quantity5,000 devices

Reason for Recall

Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

Firm 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 [email protected] 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 [email protected]

Root Cause

Process control

Distribution Pattern

NY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072248VIAPEEL PEELABLE INTRODUCEREnpath Medical, Inc. · 2007-11-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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