Mozarc Medical US LLC: Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Hazard

Potential breach of sterile barrier packaging.

Details from the source

Reason for recall: Potential breach of sterile barrier packaging. Distribution: Worldwide distribution - US Nationwide and the countries of Canada & Mexico. Quantity: 95,938 units Lot/code info: Model No.8888128459P, 8888119369P, 8888133509P, 8888123409P; UDI: 20884521157870, 20884521157733, 20884521157948, 20884521157801; Lot/Serial No. 2133600044, 2201700104, 2203300067, 2228000065, 2228000067, 2228000077, 2234800091, 2234800133, 2234800161, 2301100103, 2302500152, 2302500153, 2302500156, 2302500158, 2305300130, 2318500118, 2318500120, 2318500143, 2330300100, 2330300102, 2332700278, 2332700279, 2335200415, 2335200416, 2402400082, 2402400083, 2402400084, 2405800231, 2418000151, 2424200129, 2426300194, 2427700220.

UPC codes

20884521157870, 20884521157733, 20884521157948, 20884521157801

Source

Official record: FDA (Device enforcement) ↗

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