I.V. Catheter Recall Due to Sterilization Failures
Delta Med is recalling approximately 1,400 NEO DELTA SELFSAFE PUR 1 I.V. catheters (Lot 00A1160806) distributed in Florida and Minnesota due to sterilization process defects that may result in non-sterile devices.
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: Class II recall of a high-risk invasive medical device with potential sterilization failures. No illnesses or injuries have been reported, but non-sterile catheters pose significant risk of serious infection, matching the criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Delta Med SpA is recalling the NEO DELTA SELFSAFE PUR 1 I.V. Catheter (product reference 3718122). Approximately 1,400 units from Lot 00A1160806 are subject to this recall. The recall was initiated due to problems with the sterilization process of the devices, which may result in non-sterile catheters being supplied to patients.
Non-sterile I.V. catheters pose a serious health risk. When used in patients, they may introduce infection. This is a Class II recall issued by the U.S. Food and Drug Administration.
The affected catheters were distributed in Florida and Minnesota. Patients and healthcare providers who may have received or used catheters from Lot 00A1160806 should verify their inventory. Anyone who may have been implanted with or exposed to an affected catheter should contact their healthcare provider immediately.
The recalled product
- Product
- NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
- Manufacturer
- Delta Med SpA
- Category
- Medical Device — I.V. Catheter
- Hazard
- sterilization-failure
- 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 (1)
- Lot 00A1160806
Distribution
Distributed nationwide across the United States.
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