Device product
MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A
Z-2490-2026
Product summary
- Event
- Event 98994
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 0 units
- Official record key
device-enforcement:Z-2490-2026
Official wording
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Code information: UDI/DI 10198459556654 (each), 40198459556655 (case). Lot Numbers: 25KBC063, 25JBO955.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Derived failure modes
-
Unknown
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.