openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
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
Distribution pattern
US Nationwide. Canada, UAE
device · product 2 of 2
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
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
