Medline Soft Liner Dimensional Variation May Affect Outer Canister Fit
Medline Industries is recalling 1500ML soft liners due to dimensional variations that may make fitting into the outer canister more difficult. No injuries have been reported.
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: This is a Class II device recall with a dimensional defect affecting product fit. The recall is precautionary in nature with no reported injuries or illnesses, making this a moderate-severity issue fitting the rubric's description of voluntary precautionary recalls.
Plain-English summary
Medline Industries, LP is recalling 1500ML soft liners (Model OR926K) due to dimensional variations in the product. The dimensional variation has the potential to cause increased difficulty when fitting the product into the outer canister.
The affected products were distributed worldwide, including to healthcare facilities in the United States, Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Multiple lot numbers are affected by this recall.
No injuries or illnesses have been reported in connection with this recall. However, the dimensional variation could impact the proper fit and function of the product in its intended use.
If you have received this product, contact Medline Industries for instructions on product return or replacement.
The recalled product
- Product
- 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
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 (20)
- UDI/DI 40888277276223 (package)
- 10888277276222 (unit)
- Lot Numbers: 670220510
- 670220607
- 670220701
- 670220727
- 670220721
- 670220825
- 670221115
- 670220915
- 670220928
- 670221024
- 670221220
- 670221124
- 670221213
- 670221202
- 670221222
- 670230206
- 670230215
- 670230417
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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