DELTAVEN Y IV Catheters Recalled Over Potential Sterilization Defect
Delta Med is recalling DELTAVEN Y IV Catheters in Florida and Minnesota due to potential sterilization defects. The devices may not be properly sterilized, posing infection risks to patients.
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 FDA Class II medical device recall addresses a serious potential sterilization defect in a patient-contact device. No illnesses or injuries have been reported, and the hazard is potential rather than confirmed, warranting a High severity rating per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Delta Med SpA is recalling DELTAVEN Y Safety IV Catheters with closed system due to problems related to the sterilization of the medical devices. The affected products include four reference numbers: REF 3832072, REF 3810072, REF 3842072, and REF 3852072, each with specific lot numbers.
The sterilization process may have failed, resulting in catheters that are not properly sterilized. Non-sterile IV catheters can introduce infections and other serious complications when inserted into patients.
The recalled devices were distributed nationwide in Florida and Minnesota. The affected lot numbers are 11T80190, 11T80303, 12T80342, and 12T80348, corresponding to the reference numbers listed above.
The recalled product
- Product
- DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
- Manufacturer
- Delta Med SpA
- Category
- Medical Device — IV Catheter
- Hazard
- sterility-defect
- infection-risk
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 (5)
- a) REF 3832072
- Lot 11T80190 b) REF 3810072
- Lot 11T80303 c) REF 3842072
- Lot 12T80342 d) REF 3852072
- Lot 12T80348
Distribution
Distributed nationwide across the United States.
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