Recall Z-2804-2017 · KZH Introducer, Syringe Needle

International Medsurg Connection, Inc.

Syringe Bulb, 60 CC 50 pcs per 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.

Date	Jun 23, 2017
Status	Terminated
Reason	Insufficient documentation to support product sterility claims.
Root cause	Under Investigation by firm
Action	The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have a
Quantity	54,204,100 units total
Distribution	Nationwide 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.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.