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U.S. Department of Health and Human Services

Class 2 Device Recall FABCO

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 Class 2 Device Recall FABCOsee related information
Date Initiated by FirmAugust 02, 2022
Create DateSeptember 16, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1747-2022
Recall Event ID 90808
Product Classification Cotton, roll - Product Code EFN
ProductFABCO 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
Code Information UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428
Recalling Firm/
Manufacturer		 Carwild Corporation
3 State Pier Rd
New London CT 06320-5817
For Additional Information ContactMRS. TRUDY RICHARD
800-443-8499 Ext. 110
Manufacturer Reason
for Recall		Sterility with new cotton source not validated
FDA Determined
Cause 2		Component change control
ActionCarwild 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
Quantity in Commerce90 CASES (4500 EACHES)
DistributionUS Nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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