Fagron Inc. is voluntarily recalling all unexpired lots of LETS GEL KIT Convenience Packs at the hospital, pharmacy and distributor level. The product has been found to potentially contain microbial contamination in the non-sterile Suturagel Methylcellulose base component of the LETS GEL KIT Convenience Packs.
The U.S. Food and Drug Administration (FDA) analysis identified Bacillus fortis/Geobacillus toebii, Bacillus spp, and Bacillus circulans as contaminants in some samples obtained during an inspection of Fagron Inc. To date, Fagron Inc. has not received any reports of adverse events related to this recall.
The product is used as a topical anesthetic and is packaged in boxes containing lidocaine hydrochloride, epinephrine bitartrate, tetracaine hydrochloride, sodium metabisulfite, Suturagel Methylcellulose base, adapter cap and syringes. This non-sterile product has the potential to result in an increased chance of infection at the site of administration during open wound care. The use of this or other non-sterile products in wound treatment may increase the risk of infection, especially for immunocompromised patients, the elderly or children.
Fagron Inc. is notifying its distributors and customers by phone, email and/or letter, and is arranging for return of all recalled products. Hospitals, pharmacies and distributors that have LETS GEL KIT Convenience Packs in this recall should quarantine this material. Please immediately discontinue use or distribution of the affected lots.
This recall is being conducted with the knowledge of the FDA.
