DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Check against the official notice below — it lists the full affected range.
Medtronic is recalling DLP Pressure Disposable Pressure Display Sets, which are used during cardiopulmonary bypass surgery to extend the pressure line and reach the pressure monitoring unit. The recall affects approximately 63,053 units worldwide (48,180 in the US and 14,873 outside the US) across seven different products due to the identification of small pinholes found in a single packaging configuration of sterile pouches. The affected products were distributed to numerous countries including the US, Canada, and various nations in Europe, Asia, and other regions.
The recall involves specific lot numbers of Model 61000 and Model 62000 units manufactured between February 2016 and April 2017. The presence of pinholes in the sterile packaging could potentially compromise the sterility of the product. The record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Reason for recall: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. Distribution: 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. Quantity: 63053 (48180 US) (14873 OUS) Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.