Class 2 Device Recall Arm Sling

• Date Initiated by Firm: October 31, 2016
• Create Date: December 22, 2016
• Recall Status: Terminated on January 09, 2018
• Recall Number: Z-0888-2017
• Recall Event ID: 75649
• Product Classification: Sling, arm - Product Code ILI
• Product: Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
• Code Information: Item# Lot Number(s) SL2103 1605BC02A, 1606BC02A V'-SL2104 1605BC03A, 1606BC03A, 1607BC03A V'-SL2105 1605BC04A, 1606BC04A, 1607BC04A V'-SL2106 1605BC05A, 1606BC05A, 1607BC05A ASL2150 1605BC06A, 1607BC06A
• Recalling Firm/ Manufacturer: Owens & Minor Distribution, Inc.; 9120 Lockwood Blvd; Mechanicsville VA 23116-2015
• For Additional Information Contact: 804-723-7000
• Manufacturer Reason for Recall: Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The Product is manufactured in China by Tops Medical Articles Nantong Inc. Owens & Minor first learned of the product issue that prompted the product removal action via customer complaints received in September 2016. Two customer complaints received on September 1"1, 2016 reported surface contamination on the arm slings. Two additional complaints reported on September 19, 2016 and October 7, 2016 reported the same issue. Upon receipt of the complaints on September 1, 2016, Owens & Minor immediately initiated a CAPA investigation for root cause analysis and determination of corrective/preventive actions. A quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in May, June, and July of 2016. The surface contamination for these lots was found to be frequent. Subsequent August product lots were inspected and no surface contamination was found. Limited inventory from lots prior to May 2016 were available and inspected as well. No surface contamination was found on these prior lots. Owens & Minor has quarantined the affected product lots. The product is on hold at all Owens & Minor Distribution Centers (DC). Samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. These results are pending at this time. Based on the frequency of the product defect as well as evaluation of potential adverse health event risk, Owens & Minor initiated a voluntary recall for the above stated affected product lots.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Owens&Minor, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/9/2016 to its consignees/customers including a Recall Response Form. The letter describe the product, problem and actions to be taken. The customers were instructed to examine your inventory and identify all affected product; immediately stop using all affected product; quarantine all affected product per your facility's Standard Operating Procedures; if you have further distributed this product, identify patients/customers who received product and notify them at once; and complete and return Recall Response Form via email: www.owens-minor.com, fax to 804-723-7100, or mail to the O&M Distribution Center (DC) Attn: Recall Officer (even if you do not have any affected product). Note: upon receipt of the Recall Response Form, the DC will contact you with the appropriate RGA and instructions for product return. If you have any questions concerning credit and/or replacement of affected product or this recall, please call 804-723-7000 or contact your O&M Sales Representative or Customer Service Representative at the local O&M Distribution Center.
• Quantity in Commerce: 568 cases
• Distribution: US Nationwide Distribution.
• 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.