FDA Enforcement
Class II
Ongoing
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
Recall: Z-0157-2023
·
Reported November 9, 2022
Enforcement
- Recall Number
- Z-0157-2023
- Event ID
- 90946
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- November 9, 2022
- Initiation Date
- September 30, 2022
- Classification Date
- November 1, 2022
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
Reason
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code Info
GTIN (01) 10889942336241, Lot Number 22DBN365
Distribution
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Quantity
800 kits