FDA Recalls DELTAVEN Safety I.V. Catheters Due to Sterilization Defect
Delta Med SpA recalls 30,900 DELTAVEN Safety I.V. Catheters in Florida and Minnesota due to potential sterilization failures that could compromise device sterility.
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: FDA Class II recall of a sterile medical device (I.V. catheter) due to sterilization failure with potential loss of sterility. No illnesses, injuries, or deaths reported. Per the rubric, Class II without reported incidents and with theoretical hazard scores 3 (High).
Plain-English summary
Delta Med SpA is recalling 30,900 DELTAVEN Safety I.V. Catheter units due to problems related to device sterilization. The company has identified that affected units may have missing or compromised sterility, which could result in contaminated devices being used in patients.
The affected devices were distributed in Florida and Minnesota. Affected devices include DELTAVEN Safety I.V. Catheter in Pur with closed system under four reference numbers: REF 3836272 (Lot 11T80188), REF 3814272 (Lot 11T80272), REF 3845272 (Lot 12T80147), and REF 3856272 (Lot 12T80347). The total affected quantity is 30,900 units.
Healthcare facilities and individuals who have received these devices should immediately stop using units from the affected lots and contact Delta Med SpA for information about replacement or return. No illnesses or injuries have been reported to date. This is an FDA Class II recall.
The recalled product
- Product
- DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
- Manufacturer
- Delta Med SpA
- Category
- Medical Device
- Hazard
- sterilization-failure
- non-sterile
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 3836272
- Lot 11T80188 b) REF 3814272
- Lot 11T80272 c) REF 3845272
- Lot 12T80147 d) REF 3856272
- Lot 12T80347
Distribution
Distributed nationwide across the United States.
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