FDAFDA · Food and drugs·Recall number Z-3110-2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS981515D; d) MAJOR-LF, Pack Number DYNJ900709C; e) MAJOR-LF, Pack Number DYNJ900709D; f) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723C; g) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723D; h) CYSTO, Pack Number DYNJ908098A; i) MINOR LAPAROTOMY, Pack Number DYNJ908428; j) MERCY TIFFIN BASIC LAP-LF, Pack Number DYNJ909730
Published September 18, 2024 · Recall initiated: June 27, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Lot
- a) CDS981509C: UDI/DI case 40195327071173, UDI/DI each 10195327071172, Lot Numbers: 24ABS277; b) CDS981512J: UDI/DI case 4019532759782610195327597825, Lot Numbers: 24BBP412; c) CDS981515D: UDI/DI case 4019532707196810195327071967, Lot Numbers: 23KDC374, 24CDB523, 24EDA579; d) DYNJ900709C: UDI/DI case 4019348995099210193489950991, Lot Numbers: 23LBU953; e) DYNJ900709D: UDI/DI case 4019532763531310195327635312, Lot Numbers: 24CBQ684; f) DYNJ900723C: UDI/DI case 4019348995162310193489951622, Lot Numbers: 24ABL637; g) DYNJ900723D: UDI/DI case 4019532763534410195327635343, Lot Numbers: 24CBG030, 24CBO759, 24EBJ696; h) DYNJ908098A: UDI/DI case 4019532750725210195327507251, Lot Numbers: 24ABY035; i) DYNJ908428: UDI/DI case 4019532707116610195327071165, Lot Numbers: 24ABK094; j) DYNJ909730: UDI/DI case 4019532746453110195327464530, Lot Numbers: 24CBS071, 24EBI597
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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