Agency classClass IIOur severity:High FDA (Devices)·Z-2295-2021·Announced 2021-08-25

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.

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: 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
Affected units: 30,900

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.

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 →

High
DELTAVEN Y IV Catheters Recalled Over Potential Sterilization Defect
FDA (Devices) · 2021-08-25
High
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