Centurion Medical Products Recalls Sterile Kits Due to Incomplete Seals
Centurion Medical Products is recalling specific sterile medical kits because incomplete seals may compromise sterility.
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 risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk of infection.
Plain-English summary
Centurion Medical Products Corporation is recalling specific sterile medical kits, including various PICC, central line, and LVAD maintenance kits. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the products.
The affected products were distributed nationwide and to Ghana. The source text does not specify the exact number of units affected or the specific lot numbers for the recalled items, though a list of product codes and lot numbers is present in the metadata.
Consumers and healthcare providers should stop using the affected products and contact Centurion Medical Products Corporation for further instructions or a replacement.
The recalled product
- Product
- Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4330 PICC INSERTION TRAY CVI4340 MIDLINE INSERTION TRAY CVI4485 MOUNT SINAI CVP…
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Sterile Kits
- Affected units
- 29,020
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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