D-0265-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 7, 2018
- Initiation Date
- September 21, 2017
- Termination Date
- August 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,375 cases
Product Description
Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Reason for Recall
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Distribution Pattern
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Code Information
Pack Number: DYND74077; Lots: 16GB2754; 17GB3103; 16IB7722; 17EB6063 Pack Number: DYND74077H; Lots: 17EB6063; 17GB3103