FDA Enforcement
Class II
Ongoing
Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
Recall: Z-2358-2019
·
Reported September 4, 2019
Enforcement
- Recall Number
- Z-2358-2019
- Event ID
- 83551
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 4, 2019
- Initiation Date
- August 9, 2019
- Classification Date
- August 23, 2019
- Address
- Three Lakes Drive, N/A, Northfield, IL, 60093, United States
Description
Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
Reason
Samples in the identified lot were found to have incomplete or open packaging seals.
Code Info
Lot Number 19CAB954
Distribution
US nationwide distribution
Quantity
11962 trays