FDAOctober 31, 2016device

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 me...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 contam

What to do

FDA enforcement status: Terminated

Brands named

owens minor distributionowensowens minor

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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