Owens & Minor Recalls Medi Choice Arm Slings Due to Surface Contamination
Owens & Minor is voluntarily recalling specific lots of Medi Choice Arm Slings due to surface contamination identified through customer complaints.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a voluntary precautionary action based on surface contamination with no reported illnesses or injuries, fitting the Moderate criteria for low-risk contamination.
Plain-English summary
Owens & Minor Distribution, Inc. is voluntarily recalling 568 cases of Medi Choice Arm Slings (Item numbers ASL 2103, ASL 2104, ASL 2105, ASL 2106, and ASL 2150) distributed nationwide in the United States. The recall was initiated after customer complaints received in September and October 2016 reported surface contamination on the devices. Quality inspections confirmed that the contamination was frequent in lots manufactured in May, June, and July 2016, while lots from August 2016 and earlier showed no contamination.
The affected products are manufactured in China by Tops Medical Articles Nantong Inc. and are intended to immobilize the arm. Owens & Minor has quarantined the affected lots at all distribution centers and has sent samples to a certified testing lab to identify the specific contaminant, with results currently pending. The company initiated a Corrective and Preventive Action (CAPA) investigation to determine the root cause of the issue.
Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice. If the product matches the affected lots, it should be removed from use and returned to Owens & Minor for evaluation.
The recalled product
- 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
- Manufacturer
- Owens & Minor Distribution, Inc.
- Hazard
- Affected units
- 568
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distribution
Distributed nationwide across the United States.
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