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Recall

Class II — International Medsurg Connection, Inc.

Recalling firmINTL. MEDSURG CONNECTION, INC.
Registered facilityINTL. MEDSURG CONNECTION, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonInsufficient documentation to support product sterility claims.
ProductPiston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Quantity54,204,100 units total
DistributionNationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
Initiated2017-06-23
Classified2017-08-04
Terminated2020-08-24
Recall numberZ-2838-201
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — International Medsurg Connection, Inc. (Z-2838-201).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77658/

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