Chest Drain System Atrium 2100 mL recalled due to temperature exposure
The GETINGE OCEAN Chest Drain System Atrium 2100 mL is being recalled due to facility temperature excursions from June-August 2021 that may have impacted product effectiveness. Affected units were distributed nationwide between June 1 and September 30, 2021.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall where exposure to elevated temperatures may have impacted product effectiveness. No hospitalizations, injuries, or illnesses have been reported. The severity rating reflects that this is a risk-of-harm medical product with theoretical hazard and no confirmed injury.
Plain-English summary
The GETINGE OCEAN Chest Drain System Atrium 2100 mL (Model 2002-000) is being recalled by Mckesson Medical-Surgical Inc. This medical device is used for chest drainage in patient respiratory care.
The recall was initiated because the product was exposed to higher temperatures at the manufacturing facility between June 2021 and August 2021 prior to shipment. Exposure to these elevated temperatures may have compromised the product's effectiveness.
The recall affects all lots of this device received between June 1, 2021 and September 30, 2021. Products were distributed nationwide in the United States.
For further information or guidance regarding affected units, healthcare facilities and providers should contact Mckesson Medical-Surgical Inc. directly.
The recalled product
- Product
- GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- product-effectiveness-loss
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 (2)
- GTIN: 00650862100013
- 20650862100017
Distribution
Distributed nationwide across the United States.
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