Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450)
- Company
- Medtronic Neuromodulation
- Recall Initiated
- April 25, 2008
- Posted
- September 4, 2008
- Terminated
- May 15, 2012
- Recall Number
- Z-2168-2008
- Quantity
- 1500 pumps (20 affected)
- Firm Location
- Minneapolis, MN
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.
Distribution
USA including states of OH, DE, CT, KY, AR, NY, MA, CA, GA, NC, MI, WI, TX, PA, MD, and country of CANADA.
Lot / Code Info
Serial #: 1163101 - 1163120
Root Cause
Employee error
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.