Various ENT Packs
Reported: September 14, 2022 Initiated: June 16, 2022 #Z-1693-2022
Product Description
Various ENT Packs
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Details
- Recalling Firm
- American Contract Systems, Inc.
- Units Affected
- 3 units
- Distribution
- Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
- Location
- Kansas City, MO
Frequently Asked Questions
What product was recalled? ▼
Various ENT Packs. Recalled by American Contract Systems, Inc.. Units affected: 3 units.
Why was this product recalled? ▼
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2022. Severity: Moderate. Recall number: Z-1693-2022.
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