Centurion Pediatric PICC Insertion Tray Recalled for Connector Fluid Leakage
Centurion Medical Products is recalling Pediatric PICC Insertion Trays because they include a BD connector that may leak fluid droplets after disconnection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 leakage, which poses a risk of harm (infection or contamination) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling Pediatric PICC Insertion Trays (CVI4450) because the kits 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 involves 181,965 units distributed nationwide. The affected product codes are 2017122801 and 2018021601.
Healthcare providers and consumers should stop using the recalled trays and contact Centurion Medical Products Corporation for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- PEDIATRIC PICC INSERTION TRAY CVI4450
- 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)
- 2017122801 2018021601
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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