Centurion Neonatal PICC Insertion Tray Recalled for Packaging Compromise
Centurion Medical Products is recalling 120 Neonatal PICC Insertion Trays because the sterile packaging may be compromised, posing a risk of infection.
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 where sterile packaging may be compromised, creating a risk of harm (infection) for neonates, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling 120 units of the Neonatal PICC Insertion Tray (Kit Code: CVI2310). The recall is due to a potential for the sterile packaging to be compromised. The affected lot number is 2019043090, with an expiration date of 8/31/2020.
These kits are used for Peripheral Central Line Insertion procedures on newborns. The products were distributed nationwide in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, and WI.
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
- NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 120
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 # 2019043090 Exp: 8/31/2020
Distribution
Part of a larger recall action
This product is one of 13 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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