Medline Industries, LP: Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANTERIOR CERVICAL-SMH Medline

Hazard

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Details from the source

Reason for recall: Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. Distribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA. Quantity: 1601 units Lot/code info: Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 24KMI926; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25BMI009; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25DME458; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25FMC143; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24KME109; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24LMD416; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25BMB162; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMB403; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMK347; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25FMA695; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABJ808; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABM644; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25BBT262; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 24LBD661; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), L

UPC codes

10193489317244, 40193489317245, 10193489317183, 40193489317184, 10195327671808, 40195327671809, 10195327671723, 40195327671724, 10198459130977, 40198459130978, 10198459129889, 40198459129880, 10198459320491, 40198459320492, 10198459050671, 40198459050672, 10198459050688, 40198459050689

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.