DeRoyal Sterile Custom Kits containing Cardinal Health recall: Particulate Matter
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Why was DeRoyal Sterile Custom Kits containing Cardinal Health recalled?
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Opthalmology CSTM PCK 89-6387.08, Lot number: 49512592 exp. 07/01/2022
- Product
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
- Recalling firm
- Deroyal Industries, Inc. Lafollette
- Quantity
- 2100 units
- Distribution
- US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
- Recall date
- March 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)