FDA Enforcement
Class II
Ongoing
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Recall: Z-2302-2021
·
Reported August 25, 2021
Enforcement
- Recall Number
- Z-2302-2021
- Event ID
- 88234
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Delta Med SpA
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 25, 2021
- Initiation Date
- June 21, 2021
- Classification Date
- August 16, 2021
- Address
- Via Guido Rossa 20, N/A, Viadana, N/A, N/A, Italy
Description
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Reason
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Code Info
Lot 00A1160806
Distribution
US Nationwide distribution in the states of FL and MN.
Quantity
1400 units