Recall Z-1412-2020— Deroyal Industries, Inc. Lafollette
Class II · Terminated
Class II FDA medical device recall by Deroyal Industries, Inc. Lafollette, initiated 2020-02-04, terminated 2021-04-01. It names one FDA 510(k) clearance: K842648. Product: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08. Reason: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination..
- Recalling firm
- Deroyal Industries, Inc. Lafollette
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-04
- Terminated
- 2021-04-01
- Firm location
- La Follette, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Reason for recall
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Data sourced from openFDA. This site is unofficial and independent of the FDA.