Laser Peripherals Recalls Mislabelled Bare Laser Fibers Due to Date Error
Laser Peripherals LLC is recalling 25 units of DBLF-60-2 Bare Laser Fibers because a sterility expiration date was misprinted as '2016-16' instead of '2016-06'.
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 2/5 (Moderate).
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 and involves a minor labeling error regarding the expiration date, which fits the criteria for moderate severity involving low-risk contamination or labeling issues without reported injuries.
Plain-English summary
Laser Peripherals LLC is recalling 25 units of DBLF-60-2 Bare Laser Fibers, a sterile laser surgical instrument used in general and plastic surgery and dermatology. The recall was initiated due to a mislabeling error where the sterility expiration date was printed as '2016-16' rather than the intended date of '2016-06'.
The affected products were distributed nationwide to Illinois, Indiana, and Maryland. The specific lot codes involved in this recall are E14128 and E14129.
Healthcare providers and consumers should check their inventory for these specific lot codes and stop using the affected laser fibers immediately. The manufacturer is responsible for managing the recall and providing further instructions to affected parties.
The recalled product
- Product
- LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology
- Manufacturer
- Laser Peripherals LLC
- Hazard
- Affected units
- 25
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)
- E14128 & E14129
Distribution
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