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
- Company
- Carwild Corporation
- Recall Initiated
- August 2, 2022
- Recall Number
- Z-1747-2022
- Quantity
- 90 CASES (4500 EACHES)
- Firm Location
- New London, CT
Reason for Recall
Sterility with new cotton source not validated
Distribution
US Nationwide
Lot / Code Info
UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428
Root Cause
Component change control
Action Taken
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 : regulatory@carwild.net customerservice(@carwild.net