Medtronic Recalls DLP Pressure Display Sets Due to Packaging Pinholes
Medtronic Perfusion Systems is recalling DLP Pressure Disposable Pressure Display Sets because small pinholes were found in the sterile packaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging defect (pinholes) that compromises sterility. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic Perfusion Systems is recalling DLP Pressure Disposable Pressure Display Sets, which are used to extend pressure lines during cardiopulmonary bypass surgery. The recall was initiated after small pinholes were identified in a single packaging configuration of the sterile pouches.
The recall affects a total of seven different products, including Model No. 61000 and Model 62000. The affected units were distributed worldwide, including in the United States and numerous foreign countries such as Argentina, Australia, Canada, France, Germany, Japan, and the United Kingdom.
Healthcare providers and consumers should stop using the affected DLP Pressure Disposable Pressure Display Sets and contact Medtronic Perfusion Systems for further instructions or a replacement.
The recalled product
- Product
- DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
- Manufacturer
- Medtronic Perfusion Systems
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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