MEDLINE INDUSTRIES, LP - Northfield: MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

Hazard

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Details from the source

Reason for recall: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. Distribution: US Nationwide distribution Quantity: 224 units Lot/code info: UDI/DI 10080196415106, Lot Numbers: 506549, 508766, 509420, 512036, 512983, 514060, 514709, 516475, 516802, 517626, 518478, 518961, 519248, 519259, 519411, 519412, 519413, 519966, 519969, 520277, 522144, 522145, 527110, 527112, 528454, 528458, 528584, 531021, 531022.

UPC codes

10080196415106

Source

Official record: FDA (Device enforcement) ↗

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