DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Reported: March 11, 2020 Initiated: February 4, 2020 #Z-1419-2020
Product Description
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Reason for Recall
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Details
- Recalling Firm
- Deroyal Industries, Inc. Lafollette
- Units Affected
- 2100 units
- Distribution
- US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
- Location
- La Follette, TN
Frequently Asked Questions
What product was recalled? ▼
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13. Recalled by Deroyal Industries, Inc. Lafollette. Units affected: 2100 units.
Why was this product recalled? ▼
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2020. Severity: Moderate. Recall number: Z-1419-2020.
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