DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.

Reason: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Code information: Model No. 61000: Product UPN: 20613994846604: Lot No. 2016020865, 2016030859, 2016031538, 2016040539, 2016040859, 2016050268, 2016050556, 2016051179, 201605C063, 201605C064, 201605C065, 201605C066, 201605C067, 201605C068, 201605C069, 2016060275, 2016060525, 2016060896, 2016060897, 2016061082, 2016061083, 2016061084, 2016061476, 2016061477, 2016061478, 2016061479, 2016061480, 2016070727, 2016070744, 2016070753, 2016070962, 2016070963, 201607C046, 201607C047, 2016080349, 2016081585, 2016081586, 2016081587, 2016090237, 2016090593, 2016090594, 2016091409, 2016091410, 2016100571, 2016100572, 2016100875, 2016100876, 2016110851, 2016110852, 2016111130, 2016111131, 2016111132, 2016111133, 2016120836, 201612C037, 2017010052, 2017020120, 2017020122, 2017021065, 2017021066, 2017030114, 2017030115, 2017030116, 2017030117, 2017030118, 2017030119, 2017030595, 2017030951, 2017031135, 201703C055. Model 62000: Product UPN: 20613994846642: Lot No. 2016040236, 2016040540, 2016041196, 2016051245, 201605C015, 201605C016, 2016060226, 2016060526, 2016060899, 2016061085, 2016061086, 2016061482, 2016070542, 2016070964, 2016070965, 2016080350, 2016081588, 2016081589, 2016091146, 2016100654, 2016110453, 2016110854, 2016120837, 2017010583, 2017010945, 201701C037, 2017021067, 2017021068, 2017030596, 201703C104, 2017040147.

Distribution pattern: Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.