Class 2 Device Recall Medical Action Industries Inc. Blue OR Towel Non XRay Detectable (6 Towels per Pack)

• Date Initiated by Firm: December 11, 2017
• Create Date: May 31, 2018
• Recall Status: Terminated on September 22, 2020
• Recall Number: Z-2043-2018
• Recall Event ID: 80147
• Product Classification: Fiber, medical, absorbent - Product Code FRL
• Product: Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids. There are no instruction catalogues or manuals included with the product as these are intended to be used in accordance with hospital protocol.
• Code Information: Item Code #AVID266, Lot No. 231479, Exp. Date 08/31/2021 and Item Code #AVID266, Lot No. 232564, Exp. Date 11/06/2021.
• FEI Number: 1030451
• Recalling Firm/ Manufacturer: Medical Action Industries Inc; 25 Heywood Rd; Arden NC 28704-9302
• For Additional Information Contact: Michael Page; 828-338-7604
• Manufacturer Reason for Recall: Product sterility potentially compromised.
• FDA Determined Cause: Process control
• Action: On December 11, 2017, the firm sent letters to their consignee informing them to: Immediately examine your inventory and quarantine all product subject to this recall notification. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Replacement product should be available within the next two weeks. Should you have immediate replacement needs in the interim, we do have sufficient inventory of AVID265, Blue OR Towel Non X-Ray Detectable (4 Towels per Pack), available for immediate distribution. Your assistance is appreciated and necessary to prevent any unintended use of affected product. Please complete and return the enclosed response form as soon as possible. For further questions, please call (828_ 338-7604.
• Quantity in Commerce: 31,440 Towels
• Distribution: US Distribution to the states of : CO, KS, MN, NY, RI, TX, and WA and Internationally to Canada
• Total Product Life Cycle: TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.