Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is d

FDA device recall Z-1121-2014 · posted 2014-02-26 · Terminated

Recall details

Recalling firm

Medtronic Vascular

Reason for recall

Incorrect master label.

Action taken

Medtronic sent an Urgent Medical Device Recall letter on February 6, 2014, via UPS 3-day delivery. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product that remains in their inventory. Return the affected product to Medtronic: Contact Customer Service at 888-283-7868 and reference RADAR # 170276 to initiate a return and credit of product. Complete the attached Customers Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. If any affected product has been forwarded to another facility, customers were asked to notify that facility accordingly and facilitate the retrieval of the affected product. Customers with questions were instructed to contact their Medtronic representative. For questions regarding this recall call 888-283-7868.

Root cause

Labeling mix-ups

Status

Terminated

Product code

MAV

Quantity affected

191 devices

Distribution

Nationwide Distribution including TX, ME, IA, PA, OR, and NH.

Date initiated

2014-02-06

Date posted

2014-02-26

Date terminated

2014-06-02

Location

Danvers, MA

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