Reported Dec 28, 2016 · Terminated
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…
Owens & Minor Distribution, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Owens & Minor Distribution, Inc. · 9120 Lockwood Blvd · Mechanicsville, VA · 23116-2015
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
1/EA | 7.5 x 12.5 Inch |
1/EA | 8 x 15 Inch |
1/EA | 8.5 x 17.5 Inch |
1/EA | 9 x 20 Inch |
1/EA | 7 x 18 Inch |
- Lot codes and dates
Item# Lot Number(s) SL2103 1605BC02A1606BC02A V'-SL2104 1605BC03A1606BC03A1607BC03A V'-SL2105 1605BC04A1606BC04A1607BC04A V'-SL2106 1605BC05A1606BC05A1607BC05A ASL2150 1605BC06A1607BC06A
- Amount recalled
- 568 cases
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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