FDA Medical Device Recalls (openFDA)
Delta Med SpA: NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
- Recall number
- Z-2301-2021
- Recalling firm
- Delta Med SpA
- Product
- NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
- Status
- Open, Classified
- Initiated
- 2021-06-21
- Posted
- not on file
- Terminated
- not on file
- Reason
- Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- Root cause
- Process control
- Action
- The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.
- Quantity
- 20,000 units
- Distribution
- US Nationwide distribution in the states of FL and MN.
- Lot, serial or model codes
- a) REF 3779422, Lot 00A1160635 b) REF 3769522, Lot 00A1160656 c) REF 3708522, Lot 00A1160638
- 510(k) numbers
- ["K121007"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 3006846316
- Firm city
- Viadana
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28