Medi Choice Arm Slings ASL 2103 Small 7 — Class II medical device recall Z-0888-2017
Terminated recall by Owens & Minor Distribution, Inc., reported 2016-12-28, distributed nationwide. Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The P
| Recall number | Z-0888-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Owens & Minor Distribution, Inc., Mechanicsville, VA, United States |
| Recall initiated | 2016-10-31 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2018-01-09 |
| Distributed | Nationwide (US) |
| Quantity | 568 cases |
| Reason classes | labeling |
| Lot numbers | 1605BC02A, 1605BC03A, 1605BC04A, 1605BC05A, 1605BC06A, 1606BC02A, 1606BC03A, 1606BC04A, 1606BC05A, 1607BC03A, 1607BC04A, 1607BC05A, 1607BC06A, ASL2150, SL2103 |
| Model numbers | 1605BC02A, 1605BC03A, 1605BC04A, 1605BC05A, 1605BC06A, 1606BC02A, 1606BC03A, 1606BC04A, 1606BC05A, 1607BC03A, 1607BC04A, 1607BC05A, 1607BC06A, ASL2150, SL2103 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0888-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.