Recalls / Class II
Class IID-0266-2018
Product
Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Affected lot / code info
- Pack Number: DYND74661; Lots: 177B1602; 17RB9139; 16WB5199; 17CB7720; 17CB5841; 167B0074; 16GB8853; 16JB0621; 17EB4904; 16TB9798; 165B0465 Pack Number: DYND74661H; Lots: 17EB4904; 17CB5841; 17CB1032; 165B0465; 16WB5199; 17RB9139; 17CB7720; 16JB0621; 16TB9798; 177B1602;
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
- 14,675 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-0266-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.