Device recall: DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Class II FDA enforcement event 88234. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Class II, in the words of FDA
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
Delta Med SpA started this device recall on 21 Jun 2021. The firm address in the FDA record is in Viadana. FDA put the recall in Class II. FDA event 88234 has 11 product records. The first FDA enforcement report date is 25 Aug 2021. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of FL and MN.
Recalling firm
Delta Med SpA, Viadana, N/A, Italy.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2295-2021 | DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272 | 30,900 units | Class II | Ongoing | 25 Aug 2021 |
| Z-2296-2021 | DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572 | 203,680 units | Class II | Ongoing | 25 Aug 2021 |
| Z-2297-2021 | DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF… | 229,320 units | Class II | Ongoing | 25 Aug 2021 |
| Z-2298-2021 | DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072 | N/A | Class II | Ongoing | 25 Aug 2021 |
| Z-2299-2021 | NEO DELTA Self Safe, I.V. Catheter REF 3738222 | 10,000 units | Class II | Ongoing | 25 Aug 2021 |
| Z-2300-2021 | NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units | 5000 units | Class II | Ongoing | 25 Aug 2021 |
| Z-2301-2021 | NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522 | 20,000 units | Class II | Ongoing | 25 Aug 2021 |
| Z-2302-2021 | NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 | 1400 units | Class II | Ongoing | 25 Aug 2021 |
| Z-2303-2021 | NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 | 14,000 units | Class II | Ongoing | 25 Aug 2021 |
| Z-2304-2021 | NEO DELTA SELFSAFE PUR T, I.V. Catheter: | N/A | Class II | Ongoing | 25 Aug 2021 |
| Z-2305-2021 | WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W | 40,000 units | Class II | Ongoing | 25 Aug 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 11
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-2295-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 88234. https://recallregister.com/fda/ii/88234/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of FL and MN.
- What quantity of product is in FDA event 88234?
- The event has 11 product records. The first record gives this quantity:
30,900 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.