Device product
Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A
Z-1706-2026
Product summary
- Event
- Event 98530
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,379 kits total
- Official record key
device-enforcement:Z-1706-2026
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 10198459629334 (EA) 40198459629335 (CS) LOTS 26AMG895 2. UDI-DI 10198459545283 (EA) 40198459545284 (CS) LOTS 25LBJ366 26ABR365 3. UDI-DI 10195327471859 (EA) 40195327471850 (CS) LOTS 24EBA317 24EBV431 24IBD694 24JBQ783
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