CLASS II ONGOING Device recall · Reported 25 Aug 2021 · FDA Enforcement Report
Neo Delta Selfsafe Pur 1, I.v recalled by Delta Med SpA
Delta Med SpA is recalling Neo Delta Selfsafe Pur 1, I.v, distributed nationwide in the US. The recall was initiated on 21 Jun 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2302-2021
- FDA event ID
- 88234
- Recalling firm
- Delta Med SpA, Viadana, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jun 2021
- FDA classified
- 16 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 21 Jun 2021 | Recall initiated by company | |
| 16 Aug 2021 | Classified by FDA | +56 days |
| 25 Aug 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Where it was distributed
US Nationwide distribution in the states of FL and MN.
Questions about this recall
Is Neo Delta Selfsafe Pur 1, I.v recalled?
Yes. Delta Med SpA recalled Neo Delta Selfsafe Pur 1, I.v on 21 Jun 2021. The recall is Class II and its status is Ongoing. Recall number Z-2302-2021.
Why was it recalled?
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Which lots are affected?
Lot 00A1160806
Where was it sold?
US Nationwide distribution in the states of FL and MN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Delta Med SpA
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Deltaven Y, Safety I.V recalled by Delta Med SpA | Delta Med SpA | Sterility | Nationwide |
| Device | CLASS II | Deltaven Fastflash, Safety I.V recalled by Delta Med SpA | Delta Med SpA | Sterility | Nationwide |
| Device | CLASS II | Deltaven Safety I.V recalled by Delta Med SpA | Delta Med SpA | Sterility | Nationwide |
| Device | CLASS II | Wolf-pak Self Safe Safety IV Catheter: a) recalled by Delta Med SpA | Delta Med SpA | Sterility | Nationwide |
| Device | CLASS II | Neo Delta Selfsafe Pur T, I.v recalled by Delta Med SpA | Delta Med SpA | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |