PhotoMedex Recalls SLT Fiber Delivery Systems Due to Sterility Concerns
PhotoMedex is recalling 549 units of SLT Fiber Delivery Systems because some may not have been sealed appropriately, compromising the sterile barrier.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the sterile barrier is compromised, creating a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
PhotoMedex, Inc. is recalling 549 units of the SLT Fiber Delivery System. The product is labeled as sterile and non-pyrogenic and is indicated for the incision, excision, coagulations, and vaporization of soft tissue. The recall includes specific accessories such as the SLT-SSRH 8, SLT-SSRH 11, and various SMA models.
The firm became aware that some products within Lot number 226201 may not have been sealed appropriately. This defect compromises the sterile barrier of the device. The affected units were distributed worldwide, including in the United States (specifically Arkansas, Kansas, and Ohio) and in Germany, South Africa, and the United Kingdom.
Healthcare providers and consumers should stop using the affected products immediately. PhotoMedex is the recalling firm responsible for managing the recall.
The recalled product
- Product
- The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product…
- Manufacturer
- PhotoMedex, Inc.
- Affected units
- 549
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 226201
Distribution
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