Recalls / Class II
Class IID-0297-2018
Product
Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
- Affected lot / code info
- Pack Number: DYNDT1094 and DYNDT1094H
Why it was recalled
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recalling firm
- Firm
- Medline Industries Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Three Lakes Drive, Northfield, Illinois 60093
Distribution
- Quantity
- 2,336 cases
- Distribution pattern
- Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Timeline
- Recall initiated
- 2017-09-21
- FDA classified
- 2018-02-04
- Posted by FDA
- 2018-02-07
- Terminated
- 2023-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0297-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.