Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Reason for recall: Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom. Quantity: 833 units Lot/code info: UDI-DI: 00859373007433 Serial Numbers: 2315001 2315002 2315003 2315004 2315005 2315006 2315007 2315008 2315009 2315010 2315011 2315012 2315013 2315014 2315015 2315016 2315017 2315018 2315019 2315020 2315501 2315502 2315503 2315504 2315505 2315506 2315507 2315508 2315509 2315510 2315511 2315512 2315513 2315514 2315515 2315516 2315517 2315518 2315519 2317001 2317002 2317003 2317004 2317005 2317006 2317007 2317008 2317009 2317010 2317011 2317012 2317013 2317014 2317015 2317016 2320501 2320502 2320503 2320504 2320505 2320506 2320507 2320508 2320509 2320510 2320511 2320512 2320513 2320514 2320515 2320516 2320517 2320518 2320519 2320520 2323001 2323002 2323003 2323004 2323005 2323006 2323007 2323008 2323009 2323010 2323101 2323102 2323103 2323104 2323105 2323106 2323107 2323108 2323109 2323110 2325001 2325002 2325003 2325004 2325005 2325006 2325007 2325008 2325009 2325010 2325011 2325012 2325013 2325014 2325015 2327201 2327202 2327203 2327204 2327205 2327206 2327207 2327208 2327209 2327210 2328101 2328102 2328103 2328104 2328105 2328106 2328107 2328108 2328109 2328110 2328111 2332101 2332102 2332103 2332104 2332105 2332106 2332107 2332108 2332109 2332110 2332111 2332112 2332113 2332114 2332115 2332116 2332117 2332118 2332119 2332120 2338701 2338702 2338703 2338704 2338705 2338706 2338707 2338708 2338709 2338710 2338711 2338712 2338713 2338714 2338715 2338716 2338717 2338718 2338719 2338720 2339201 2339202 2339203 2339204 2339205 2339206 2339207 2339208 2339209 2339210 2339211 23392
00859373007433
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.