Cardinal Health 200, LLC: Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-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. AT6588-2XL UDI-DI: CS (01) 50885380166639 EA (01) 20885380166638; AT6588-BD UDI-DI: CS (01) 50885380166646 EA (01) 20885380166645; AT6588-XL UDI-DI: CS (01) 50885380166653 EA (01) 20885380166652; AT6688-2XL UDI-DI: CS (01) 50885380166660 EA (01) 20885380166669; AT6688-BD UDI-DI: CS (01) 50885380166677 EA (01) 20885380166676; AT6688-XL UDI-DI: CS (01) 50885380166684 EA (01) 20885380166683

UPC codes

50885380166639, 20885380166638, 50885380166646, 20885380166645, 50885380166653, 20885380166652, 50885380166660, 20885380166669, 50885380166677, 20885380166676, 50885380166684, 20885380166683

Source

Official record: FDA (Device enforcement) ↗

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