Recall Z-0888-2017 ยท ILI Sling, Arm
Owens & Minor Distribution, Inc.
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.
| Date | Oct 31, 2016 |
| Status | Terminated |
| Reason | 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 |
| Root 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 vi |
| Quantity | 568 cases |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.