Cardinal Health 200, LLC: Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL

Hazard

Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.

Details from the source

Reason for recall: Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements. Distribution: US Nationwide. Canada, UAE Quantity: 940,203 total units Lot/code info: All Lots. AT6100 UDI-DI: CS (01) 50192253048252 EA (01) 20192253048251; AT6100-XL UDI-DI: CS (01) 50192253048269 EA (01) 20192253048268; AT6200 UDI-DI: CS (01) 50192253048276 EA (01) 20192253048275; AT6200-XL UDI-DI: CS (01) 50192253048283 EA (01) 20192253048282

UPC codes

50192253048252, 20192253048251, 50192253048269, 20192253048268, 50192253048276, 20192253048275, 50192253048283, 20192253048282

Source

Official record: FDA (Device enforcement) ↗

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