Recalls / Class II
Class IID-0315-2018
Product
Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Affected lot / code info
- Pack Number: P888943; Lots 17RB8662 Pack Number: P888937H; Lots 17QB8268
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
- 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-0315-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.