Bencox Mirabo PE Liner Recalled for Incorrect Instruction Manual
Corentec Co., Ltd. is recalling five units of Bencox Mirabo PE Liners distributed in Pennsylvania because they may contain Chinese instructions instead of US instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and labeling issue (incorrect instruction manual) with no reported injuries or health hazards.
Plain-English summary
Corentec Co., Ltd. is recalling five units of the Bencox Mirabo PE Liner 36/44 (Model Number: H1.L61.3644, UDI: 8806373852343). The recall affects Lot Number 10AFFQ21, which has an expiration date of November 28, 2021. The product was distributed in the state of Pennsylvania.
The recall was initiated because the lot may contain the wrong instruction manual. Specifically, the devices may include instructions intended for Chinese customers rather than the correct US instructions for use.
Consumers who possess these specific units should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
- Manufacturer
- CORENTEC CO., LTD
- Hazard
- Affected units
- 5
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 (1)
- Lot Number: 10AFFQ21 Expiration Date: 2021-11-28
Distribution
Distributed in 1 state:
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