Viadana, N/A, Italy
Delta Med SpA recalls
1 recall recorded since 2018, most recently on 21 June 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 June 2021
- Reason
- Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- Distribution
- US Nationwide distribution in the states of FL and MN.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2300-2021, Z-2299-2021, Z-2304-2021, Z-2301-2021, Z-2296-2021, Z-2303-2021, Z-2305-2021, Z-2295-2021, Z-2297-2021, Z-2302-2021, Z-2298-2021
- NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
- NEO DELTA Self Safe, I.V. Catheter REF 3738222
- NEO DELTA SELFSAFE PUR T, I.V. Catheter:
- NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
- 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
- NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
- WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
- DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
- and 3 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.