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  4. Fagron Inc. Issues Voluntary Nationwide Recall of LETS GEL KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products
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COMPANY ANNOUNCEMENT

Fagron Inc. Issues Voluntary Nationwide Recall of LETS GEL KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Potentially contain microbial contamination in the non-sterile Suturagel
Company Name:
Fagron Inc.
Brand Name:
Brand Name(s)
Fagron
Product Description:
Product Description
LETS GEL KIT Convenience Packs

Company Announcement

Fagron Inc. is voluntarily recalling all unexpired lots of LETS GEL KIT Convenience Packs to 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. 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. Fagron Inc. places the health and well being of patients first and focuses on quality throughout our production processes. Fagron Inc. will contact all affected customers via a recall letter to arrange for the return of all products identified in the 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. The affected LETS GEL KIT Convenience Pack lots include the following lot numbers and expiration dates:

Lot Number Expiration Date
18F25-U03-044296 11/8/2019
18F25-U04-044297 11/8/2019
18H22-U06-045284 1/24/2020
18I24-U05-045853 11/8/2019
18K06-U03-047041 1/24/2020
18K06-U04-047042 1/24/2020
18K27-U11-047460 3/16/2020
18K28-U10-047519 3/16/2020
19A06-U02-048182 3/16/2020
19A06-U03-048183 3/16/2020
19A16-U13-048363 3/16/2020
19A21-U02-048503 3/16/2020
19B10-U02-048787 3/16/2020
19B14-U05-048781 3/16/2020
19C05-U01-049199 3/16/2020
19C05-U02-049200 3/16/2020
19C11-U07-049451 3/16/2020
19C25-U02-048758 3/16/2020
19D07-U01-049884 3/16/2020
19D07-U02-049885 3/16/2020
19E09-U01-050298 3/16/2020
19E23-U01-050763 9/11/2020
19F16-U12-000052 9/11/2020
19F16-U13-000053 10/24/2020
19G07-U01-000357 10/24/2020
19G07-U02-000358 10/24/2020
19G21-U01-000930 10/24/2020
19G21-U02-000931 12/17/2020
19H01-U01-001172 12/17/2020
19H01-U02-001174 12/17/2020
19I03-U01-002019 2/4/2021
19I03-U02-002020 2/4/2021
19I03-U03-002021 12/17/2020

The product can be identified by the product packaging and labeling. The product was distributed nationwide to hospitals, pharmacies and distributors.

Fagron Inc. is notifying its distributors and customers by phone, e-mail, and/or letter and is arranging for return of all recalled products. Hospitals, pharmacies and distributors that have LETS GEL KIT Convenience Packs which are being recalled should quarantine this material. Please immediately discontinue use or distribution of the affected lots.

Consumers with questions regarding this recall can contact Stericycle via the following information.

Phone: 877-448-5308 (8am – 5pm EST)
FAX: 877-884-9410
Email: Fagron7222@stericycle.com

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using the product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
Stericycle
877-448-5308
Fagron7222@stericycle.com
Media:
Jim Bergan
651-313-6536

Product Photos