The Recall Desk
ModerateFDA (Devices)·Z-2073-2014·Announced 2014-07-23

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'.

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 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
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

Distributed nationwide across the United States.

The notice also names 3 states specifically: