Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K210

FDA device recall Z-2168-2008 · posted 2008-09-04 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.

Action taken

Affected customers contacted by letter "Medtronic Urgent: Medical device Recall April 2008" that indicates that some Medela Vario 18 Vacuum Pumps were provided with an incorrect Suction Jar Lid that did not have the correct Conical Connection for the Vacuum Tube and the method to obtain a replacement part if needed. The letter requires customers to locate the Vacuum Pump serial number and compare it against the Serial Number on the Reply Form provided. Next customers are to review the Suction Jar Lid and check the part number. "Reply form and Instruction for Receiving Replacement Lid " included. Contact Medtronic 1-800-707-0933 for assistance.

Root cause

Employee error

Status

Terminated

Product code

BTA

Quantity affected

1500 pumps (20 affected)

Distribution

USA including states of OH, DE, CT, KY, AR, NY, MA, CA, GA, NC, MI, WI, TX, PA, MD, and country of CANADA.

Date initiated

2008-04-25

Date posted

2008-09-04

Date terminated

2012-05-15

Location

Minneapolis, MN

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