Recalls / Class II
Class IID-0310-2018
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: MDS708555; Lots 17SB5603; 17PB8319; 177B2065; 17DB2104; 17RB9448; 17RB9451; 17PB8314; 17HB5104; 16XB1090; 17QB0860; 16OB0307; 17DB2777; 16UB2803; Pack Number: MDS708555H; Lots 17PB8319; 173B2496; 16UB2803; 16XB1090; 16SB4453; 16RB1126; 17DB2777; 17QB0860; 16TB8928; 17PB8314; 16IB3745; 17RB9451; 17DB2104; 164B2214; 16KB5659
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
- 195,448 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-0310-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.