DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
FDA device recall Z-1412-2020 · posted 2020-02-19 · Terminated
Recall details
- Recalling firm
- Deroyal Industries, Inc. Lafollette
- Reason for recall
- Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Action taken
- DeRoyal issued their recall on 1/26/2020 to the end user level by sending recall letters to its direct accounts. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 2100 units
- Distribution
- US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
- Date initiated
- 2020-02-04
- Date posted
- 2020-02-19
- Date terminated
- 2021-04-01
- Location
- La Follette, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL SURGERY TRAY (K842648) | Deroyal Industries, Inc. | 1984-09-20 |