Centurion Chest Tube Trays Recalled for Incomplete Package Seals
Centurion Medical Products is recalling 448 chest tube trays 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 (compromised sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling 448 units of Centurion Chest Tube Trays. The affected products include various chest tube insertion trays and chest trays, identified by specific kit codes and lot numbers. The recall was initiated because incomplete seals on the sterile package may compromise the sterility of the devices.
The affected products were distributed nationwide and to Ghana. The specific lot numbers associated with the recall are 2019011690, 2018111490, 2019031490, 2019050890, 2019050690, 2019012590, 2018110890, and 2019010290.
Healthcare facilities and consumers should stop using these products and contact Centurion Medical Products Corporation for further instructions or a refund.
The recalled product
- Product
- Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY CHT1760 CHEST TRAY CHT275 CHEST TUBE INSERTION TRAY CHT440 CHEST TUBE INSERTION TRAY CHT701 CHEST TUBE INSERTION TRAY CHT760 CHEST TUBE…
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 448
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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