Mozarc Medical US LLC: Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lum

Hazard

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

Details from the source

Reason for recall: The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. Distribution: US Nationwide distribution. Quantity: 25627 Lot/code info: 1. Product Number (CFN): 8888221413; UDI-DI: 10884521788541; Lot numbers: 241620022, 252020038; 2. Product Number (CFN): 8888222416; UDI-DI: 10884521788602; Lot numbers: 241690023, 241830147; 3. Product Number (CFN): 8888221416; UDI-DI: 10884521788558; Lot numbers: 251250041, 251740190, 252020039, 252090031, 253350256; 4. Product Number (CFN): 8888222420; UDI-DI: 10884521788619; Lot numbers: 251740186, 252510026, 253280016; 5. Product Number (CFN): 8888221420; UDI-DI: 10884521788565; Lot numbers: 241620407, 251950032; 6. Product Number (CFN): 8888222424; UDI-DI: 10884521788626; Lot number: 243040007; 7. Product Number (CFN): 8888221424; UDI-DI: 10884521788572; Lot numbers: 241200034, 251250039, 252020037; 8. Product Number (CFN): 8888221430; UDI-DI: 10884521788589; Lot number: 251250042; 9. Product Number (CFN): 8888233413; UDI-DI: 10884521788718; Lot number: 250310009; 10. Product Number (CFN): 8888233416; UDI-DI: 10884521788725; Lot numbers: 250350008, 250690152, 250690153, 250870012, 251010012, 251010013, 251320332, 251320333, 251390368, 251390369, 252580023; 11. Product Number (CFN): 8888233420; UDI-DI: 10884521788732; Lot numbers: 250870013, 250970052, 251320330, 251320331; 12. Product Number (CFN): 8888231420; UDI-DI: 10884521788688; Lot numbers: 241690216, 252020046, 252230023, 252580025; 13. Product Number (CFN): 8888233424; UDI-DI: 10884521788749; Lot numbers: 251740197, 252300054; 14. Product Number (CFN): 8888231424; UDI-DI: 10884521788695; Lot numbers: 251460351,

UPC codes

10884521788541, 10884521788602, 10884521788558, 10884521788619, 10884521788565, 10884521788626, 10884521788572, 10884521788589, 10884521788718, 10884521788725, 10884521788732, 10884521788688, 10884521788749, 10884521788695, 10884521788701, 10884521788664, 10884521788671, 10884521788527, 10884521788435, 10884521788534, 10884521788442, 10884521788473, 10884521788428, 10884521788480, 10884521788497, 10884521788459

Source

Official record: FDA (Device enforcement) ↗

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