Medical Device Advisories

FDA Advisory No. 2017-084 || HEALTH WARNING ON USING COVIDIEN VALLEYAB LAPAROSCOPIC HANDSET (FOUR-FUNCTION) WITH PRODUCT CODE E2750

FDA Advisory No. 2017-084

HEALTH WARNING ON USING COVIDIEN VALLEYAB LAPAROSCOPIC HANDSET (FOUR-FUNCTION) WITH PRODUCT CODE E2750

All are hereby advised by the Food and Drug Administration (FDA) about the lots of the following laparoscopic handsets with product code E2750 distributed by Medtronic Philippines Inc. 32nd Street Bonifacio Global City, Fort Bonifacio Taguig City:

PRODUCT CODE

DESCRIPTION

Lot Numbers

E2750

Valleylab Laparoscopic Handsets Four-Function

52990142X

53250061X

53610059X

60240065X

61220095X

52990144X

53250063X

53610061X

60520098X

61220098X

52990147X

53250065X

60240055X

60520104X

61300164X

52990151X

53610053X

60240059X

60870064X

61540145X

53250057X

53610055X

60240061X

61220093X

61540150X

The cited product are being voluntarily recalled by Medtronic Philippines Inc. because of the customer reports from its main manufacturer in other country on potential defect/malfunction of the device. In the report, the handset continues to operate upon release of the activation button. If it does not deactivate after release of activation button, it presents safety risk and possible health consequences like damage to the internal tissues.

Distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. All consumers are likewise advised not to purchase or use the affected product lots.

Any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to FDA at telephone no. (02) 857-1900 loc. 8301 or email us at This email address is being protected from spambots. You need JavaScript enabled to view it..

Dissemination of the information to all concerned is requested.

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