FDA Recalls DELTAVEN Y Safety IV Catheters Due to Sterilization Issues
Delta Med SpA is recalling DELTAVEN Y DNL Safety IV Catheters with closed system due to sterilization problems. The recalled units may lack proper sterility and pose a risk 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 is an FDA Class II recall of a critical medical device (IV catheter) with potential sterilization failure. No illnesses or injuries have been reported. The hazard is significant as sterile IV catheters are essential for patient safety, qualifying this as a risk-of-harm product without yet-reported injury.
Plain-English summary
DELTAVEN Y DNL Safety IV Catheters with closed system (7 product references with multiple lot numbers) are being recalled due to sterilization problems. The recall affects 203,680 units distributed in Florida and Minnesota.
The FDA has determined that problems related to sterilization may have resulted in some units lacking proper sterility assurance, which is critical for safe intravenous catheter use.
Healthcare providers should immediately stop use of the affected lots and contact the manufacturer for return and replacement instructions. Patients who received these catheters should discuss any health concerns with their healthcare provider.
The recalled product
- Product
- DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
- Manufacturer
- Delta Med SpA
- Hazard
- lack-of-sterility
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 (7)
- a) REF 3832572: Lot 11T80189 b) REF 3842572
- Lot 11T80198 c) REF 3821572
- Lot 11T80149 d) REF 3833572
- Lot 11T80292 e) REF 3831572
- Lot 12T80230 f) REF 3810572
- Lot 12T80302 g) REF 3852572
- Lot 12T80349
Distribution
Distributed nationwide across the United States.
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