Agency classClass IIOur severity:High FDA (Devices)·Z-2302-2021·Announced 2021-08-25

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 1,400

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.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 11 recalled by Delta Med SpA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Same manufacturer · Delta Med SpA

See all →

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DELTAVEN Y IV Catheters Recalled Over Potential Sterilization Defect
FDA (Devices) · 2021-08-25
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I.V. Catheter Recall: Sterilization Defects in NEO DELTA Self Safe Devices
FDA (Devices) · 2021-08-25
High
I.V. Catheter Recall Due to Possible Sterilization Failure
FDA (Devices) · 2021-08-25
High
NEO DELTA Self Safe T IV Catheters Recalled for Sterilization Failure
FDA (Devices) · 2021-08-25
High
FDA Recalls DELTAVEN Y Safety IV Catheters Due to Sterilization Issues
FDA (Devices) · 2021-08-25

Same hazard · sterilization failure