Recall Z-2304-2021— Delta Med SpA
Class II · Ongoing
Class II FDA medical device recall by Delta Med SpA, initiated 2021-06-21. It names one FDA 510(k) clearance: K121007. Product: NEO DELTA SELFSAFE PUR T, I.V. Catheter:. Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device.
- Recalling firm
- Delta Med SpA
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-06-21
- Firm location
- Viadana, N/A, Italy
510(k) clearances named in this recall
1 on FDA's record- K121007 — NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Reason for recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Data sourced from openFDA. This site is unofficial and independent of the FDA.