Recalls / Class II
Class IID-0307-2018
Product
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
- Affected lot / code info
- Pack Number: MDS701550; Lots 16GB7687; 17HB5153; 16IB0427; 17GB3906; 17AB1937; 17CB7737; 16JB1136; 16JB1137 Pack Number: MDS701550H; Lots 16QB4583; 16IB0427; 17CB7737; 16MB6165; 17GB3906; 17AB1937; 16GB7687; 16JB1137; 17HB5153
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
- 49,587 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-0307-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.