Chest Tube Insertion Tray Recalled Due to Over-Sterilization of Suture Component
Medline recalls CENTURION SnagFree Chest Tube insertion trays because a silk suture component was sterilized twice instead of once, potentially compromising its integrity. The affected lot contains 18 kits distributed in California and Texas.
What this means for you
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: This is an FDA Class II medical device recall involving a surgical component (silk suture) that was not processed according to specifications. Although no illnesses or injuries have been reported, the affected chest tube insertion tray poses a potential risk of harm during use if the over-sterilized suture component fails or loses integrity.
Plain-English summary
Medline Industries is recalling CENTURION SnagFree Chest Tube insertion trays (model CHT545) because one lot of 18 kits was subjected to a processing error that does not meet product specifications.
The chest tube insertion tray contains a silk suture component that is restricted to one sterilization cycle. The affected lot was processed through two sterilization cycles, which may compromise the integrity of the suture component.
The affected kits were distributed in California and Texas. No reported illnesses or injuries have been associated with this recall.
The recalled product
- Product
- CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 18
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 (2)
- UDI/DI 20653160222979
- Lot Code 2022050690
Distribution
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