Z-1747-2022Class II

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...

Name: Z-1747-2022 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...
Creator: Carwild Corporation
Published: 2022-08-02
License: https://open.fda.gov/license/

Carwild Corp. / initiated 2022-08-02 / Open, Classified / root cause: sterility

FDA source

Carwild Corporation began a recall of 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 on 2022-08-02. FDA classified it as Class II and gives the reason as "Sterility with new cotton source not validated". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1747-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-02
Posted: 2022-09-16
Recalling firm: Carwild Corp.
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
Product code: EFN Cotton, Roll
Reason for recall: Sterility with new cotton source not validated
Root cause tag: sterility
FDA root cause: Component change control
Action: Carwild Corp. issued Recall Urgent Notice via email on 8/2/22 in a pdf form fillable document for Distributors/Direct accounts to complete and return. Letter states reason for recall, health risk and action to take: 1. Discontinue use of this product and Immediately place inventory of this product on HOLD. Distributors to provide traceability of lot. 2. Complete and return the attached RECALL NOTICE to us. 3. Once we receive the completed RECALL NOTICE, we will make arrangements for the product to be returned. Please respond immediately to confirm receipt of this email. Call for questions or additional Regulatory (Voice) information. 1-860-442-4914 x111 Please introduce as inquiry Customer Service related to RECALL NOTICE 1-860-442-4914 x110. PRODUCT RECALL and RESPONSE : [email protected] customerservice(@carwild.net
Quantity in commerce: 90 CASES (4500 EACHES)
Distribution: US Nationwide
Product codes and lots: UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1747-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1747-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-15

Product code EFN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)