Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case, 2,400/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.
FDA Recall Z-2831-2017 · Posted None
Advertisement
Recalling FirmInternational Medsurg Connection, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2017-06-23
Date Terminated2020-08-24
Product Quantity54,204,100 units total
Reason for Recall
Insufficient documentation to support product sterility claims.
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: [email protected]; phone at 847-619-9926 or fax to 847-619-9927.
If you have any questions, contact Quality Manager at 847-619-9926 or email: [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement