Centurion Ultrasound Guided PIV Kit Recalled for Incomplete Seals
Centurion Medical Products Corporation is recalling 350 ultrasound guided PIV kits due to incomplete sterile package seals that may compromise sterility.
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 involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling 350 units of the Centurion IVS3505 Ultrasound Guided PIV Kit. The recall is due to incomplete seals on the sterile package, which may compromise the sterility of the device.
The affected product is identified by Lot Code 2019012390. The recall covers units distributed nationwide and in Ghana.
Healthcare facilities and consumers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions or a return.
The recalled product
- Product
- Centurion IVS3505 ULTRASOUND GUIDED PIV KIT
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — IV Kits
- Hazard
- Affected units
- 350
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)
- Lot Code: 2019012390
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 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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