Device product
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Z-1708-2026
Product summary
- Event
- Event 98530
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,379 kits total
- Official record key
device-enforcement:Z-1708-2026
Official wording
Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Code information: 1. UDI-DI 10195327501259 (EA) 40195327501250 (CS) LOTS 24DBW065 24EBV301 24HBB492 24JBW143 25ABG413 25CBH359 25DBD213 25GBP569 25HBQ088 25KBF725 26ABE643 2. UDI-DI 10195327371029 (EA) 40195327371020 (CS) LOTS 24FBM018 24GBL319
Distribution pattern: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
Derived failure modes
-
Foreign material or chemical contamination
foreign body