November 04, 2019
LETS GEL KIT Convenience Packs by Fagron Recall
A MedWatch Safety Alert was just added to the FDA Recalls webpage.
TOPIC: LETS GEL KIT Convenience Packs by Fagron: Recall - Due to Potential Microbial Contamination of Non-Sterile Products
AUDIENCE: Anesthesiology, Health Professional, Pharmacy, Risk Manager, Consumer
BACKGROUND: LETS GEL KIT Convenience Packs are used as a topical anesthetic and packaged in boxes containing lidocaine hydrochloride, epinephrine bitartrate, tetracaine hydrochloride, sodium metabisulfite, suturagel methylcellulose base, an adapter cap and syringes.
ISSUE: Fagron Inc. is voluntarily recalling all unexpired lots of LETS GEL KIT Convenience Packs because 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. FDA analysis identified bacillus fortis/geobacillus toebii, bacillus spp, and bacillus circulans as contaminants in some samples obtained during an inspection of Fagron Inc.
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. To date, Fagron Inc. has not received any reports of adverse events related to this recall.
Please click on the "Read Recall" button below to view a list of the affected lots.
RECOMMENDATION: Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using the product.
Health care providers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.