Z-3111-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- June 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6257 units
Product Description
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO BASIC KIT, Pack Number DYKE1356; c) ENDOSCOPY KIT, Pack Number DYKE1771C
Reason for Recall
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Code Information
a) DYKE1355: UDI/DI case 40889942274193, UDI/DI each 10889942274192; Lot Numbers: 23LBB043, 24BBJ327, 24CBS751; b) DYKE1356: UDI/DI case 40889942274186, UDI/DI each 10889942274185; Lot Numbers: 23LBD062, 24ABA646, 24BBJ328, 24CBG449, 24DBE106, 24EBG238; c) DYKE1771C: UDI/DI case 40195327331994, UDI/DI each 10195327331993; Lot Numbers: 24ABX292