Medtronic DLP Antegrade/Retrograde Adapter Recalled for Packaging Pinholes
Medtronic is recalling DLP Antegrade/Retrograde Adapters because small pinholes were found in a single packaging configuration of sterile pouches.
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 the DLP Antegrade/Retrograde Adapter, a medical device used for the perfusion of cardioplegia in either an antegrade or retrograde fashion. The recall involves a total of seven different products.
The recall was initiated due to the identification of small pinholes in a single packaging configuration of sterile pouches. This defect affects the integrity of the sterile packaging for the affected units.
The affected products were distributed worldwide, including in the United States and numerous foreign countries. Consumers and healthcare providers should stop using the affected products and contact Medtronic Perfusion Systems for further instructions.
The recalled product
- Product
- DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Cardiac Surgery
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. 13001
- Product UPN 20613994677611
- Lot No. 2016020795
- 2016030222
- 2016030813
- 2016031019
- 2016040411
- 2016040614
- 201604C004
- 2016050516
- 2016050769
- 2016051176
- 2016060227
- 2016061042
- 2016061440
- 2016070193
- 2016070921
- 2016070922
- 2016080373
- 2016090545
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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