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
Reported: December 18, 2024 Initiated: November 1, 2024 #Z-0675-2025
Product Description
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
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.
Details
- Recalling Firm
- Cardinal Health 200, LLC
- Units Affected
- 940,203 total units
- Distribution
- US Nationwide. Canada, UAE
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cardinal Health 200, LLC. Units affected: 940,203 total units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2024. Severity: Moderate. Recall number: Z-0675-2025.
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