Centurion Neonatal PICC Trays Recalled for Incomplete Sterile Package Seals
Centurion Medical Products is recalling 957 Neonatal PICC Trays due to incomplete seals that may compromise sterility. The units were distributed nationwide and to Ghana.
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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) for a medical device where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling 957 units of Neonatal PICC Trays and related kits. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the medical devices.
The affected products include various Neonatal PICC Insertion Trays, Peds PICC Insertion Trays, and NICU PICC Insertion Kits. Specific lot numbers are listed in the recall documentation, including lots 2018122190, 2019061190, 2019020190, 2019010490, and 2018101190.
The products were distributed nationwide and to Ghana. Healthcare facilities and consumers should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI3650 PEDS PICC INSERTION TRAY CVI3730 NEONATAL PICC…
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 957
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.
See all 54 products in this recall →Related recalls
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