Fabco ORS Dental Rolls recall: Sterility Concern
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
Why was Fabco ORS Dental Rolls recalled?
Sterility with new cotton source not validated
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428
- Product
- FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
- Recalling firm
- Carwild Corporation
- Quantity
- 90 CASES (4500 EACHES)
- Distribution
- US Nationwide
- Recall date
- September 21, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)