FDA Enforcement
Class I
Ongoing
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Recall: Z-2254-2024
·
Reported July 17, 2024
Enforcement
- Recall Number
- Z-2254-2024
- Event ID
- 94793
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Synergetics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 17, 2024
- Initiation Date
- June 12, 2024
- Classification Date
- July 11, 2024
- Address
- 3845 Corporate Centre Dr, N/A, O Fallon, MO, 63368-8678, United States
Description
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Reason
Sterilization certificates could not be validated by the supplier
Code Info
UDI/DI 20841305107612, Lot Number P62764970R
Distribution
US Nationwide
Quantity
35 units