Recall Z-2850-2017 ยท FMF Syringe, Piston
International Medsurg Connection, Inc.
Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/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
| K102969 | IMC PISTON SYRINGES International Medsurg Connection, Dec 20, 2010 |