Exelint International Co. Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S).
Brand
Exelint International Co.
Lot Codes / Batch Numbers
Catalog 37854S Lot 09G31, Catalog 37855S Lot 09G31, Catalog 37858S Lot 09G31.
Products Sold
Catalog 37854S Lot 09G31; Catalog 37855S Lot 09G31, Catalog 37858S Lot 09G31.
Exelint International Co. is recalling Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S). due to Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pul. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port
Recommended Action
Per FDA guidance
Distributors have been advised to cease distribution of any recalled needles and infusion sets; to quarantine any remaining; to document amount on Customer Response Form; to return form to Exel (firm); to arrange for return of product to Exel for credit. Distributors also are advised to share recall notice with all affected customers. Contact phone: 727-827-1922x0 (M-F 9a-5p EST). Contact email: info@exelint.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, DE, FL, GA, IL, IA, KY, LA, MI, MS, MO, NV, NH, NJ, NM, NY, OH, OR, PA, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026