Centurion Medical Invasive Procedure Tray Recall for Connector Defect
Centurion Medical Products is recalling Invasive Procedure Trays because they include a recalled connector that may release fluid droplets.
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: The recall is classified as FDA Class II. The hazard involves a risk of fluid exposure from a medical device, which fits the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling the Invasive Procedure Tray MNS9510. The recall involves 181,965 units that were distributed nationwide. The trays include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer due to a defect.
The defect involves the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection. This issue is associated with the specific connector component included in the kits.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled product. No illnesses or injuries are reported in the provided text.
The recalled product
- Product
- INVASIVE PROCEDURE TRAY MNS9510
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 181,965
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 (1)
- 2017100990 2017120490
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 recalled by Centurion Medical Products Corporation 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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