Class 2 Device Recall Blue OR Towels

• Date Initiated by Firm: April 19, 2017
• Create Date: May 17, 2017
• Recall Status: Open, Classified
• Recall Number: Z-2102-2017
• Recall Event ID: 77063
• Product Classification: Gauze/sponge, internal, x-ray detectable - Product Code GDY
• Product: Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
• Code Information: Material Number: AVID260, Lot #231253, Exp. Date: 10/31/2021 (48 pk) and Material Number: MSPT504, Lot #229259, Exp. Date: 10/12/2021 (20 pk).
• Recalling Firm/ Manufacturer: Medical Action Industries Inc; 25 Heywood Rd; Arden NC 28704-9302
• For Additional Information Contact: Nichole K Early; 828-681-8820 Ext. 258
• Manufacturer Reason for Recall: Lint present on sterile Operating Room Towels.
• FDA Determined Cause: Other
• Action: Consignees were notified via Medical Device Notification of Recall notice on/about 4/19/2017.
• Quantity in Commerce: 38 cases (3-48pk/35-20pk)
• Distribution: AR, IN and NV.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.