Cook Incorporated: COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G2475

Hazard

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Details from the source

Reason for recall: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Distribution: Worldwide distribution. Quantity: 5080 units Lot/code info: Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260424(10)15569919, Lot Number 15569919; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260403(10)15520378, Lot Number 15520378; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15487727, Lot Number 15487727; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15484947, Lot Number 15484947; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)16617145, Lot Number 16617145; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617419, Lot Number NS16617419; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617420, Lot Number NS16617420; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620091, Lot Number NS16620091; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620092, Lot Number NS16620092; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620093, Lot Number NS16620093; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620094, Lot Number NS16620094; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620414, Lot Number NS16620414; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620415, Lot Number NS16620415; Reference Part Number C-UDLM-401J-ABRM

UPC codes

00827002439832, 00827002247543, 00827002439863, 00827002439849, 00827002247529, 00827002439856, 00827002439955, 00827002439962, 00827002439979, 00827002508170, 00827002515376, 00827002515390, 00827002440050, 00827002248038, 00827002440081, 00827002440067, 00827002440074, 00827002247659, 00827002478251, 00827002248090, 00827002535992, 00827002478275, 00827002478299, 00827002248106

Source

Official record: FDA (Device enforcement) ↗

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