Centurion Pediatric PICC Insertion Tray Recalled for Connector Fluid Droplet Risk
Centurion Medical Products is recalling Pediatric PICC Insertion Trays because they include a BD connector that may release fluid droplets after disconnection.
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 medical device with a potential for fluid droplet separation, which poses a risk of harm (infection or contamination) but does not have reported injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Centurion Medical Products Corporation is recalling Pediatric PICC Insertion Trays (CVI4450A) because they include the BD MaxZeroNeedleess Connector. The connector was recalled by its manufacturer due to a potential for droplets of fluid to separate from the sealed surface following disconnection.
The recall covers 181,965 units distributed nationwide. Affected lots include codes 2018101250, 2018101850, 2018110950, and 2018121150.
Healthcare facilities and consumers should stop using these trays and contact Centurion Medical Products Corporation for instructions on return or replacement.
The recalled product
- Product
- PEDIATRIC PICC INSERTION TRAY CVI4450A
- 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)
- 2018101250 2018101850 2018110950 2018121150
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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