Why it was recalled
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Product description
Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Lot numbers, UPCs & expiration codes
Pack Number: DYNDINSERTKIT; Lots: 17SB3347; 175B1052; 16JB3251; 16IB2940; 17CB4925
Where it was sold
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0276-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2017
- FDA report date
- Feb 7, 2018
- Quantity
- 4,100 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medline Industries Inc
Original FDA data
Every field from FDA enforcement report D-0276-2018, exactly as published.
Show all FDA fields
- City
- Northfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78575
- Address
- Three Lakes Drive
- Code information
- Pack Number: DYNDINSERTKIT; Lots: 17SB3347; 175B1052; 16JB3251; 16IB2940; 17CB4925
- Postal code
- 60093
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0276-2018
- Classification
- Class II
- Recalling firm
- Medline Industries Inc
- Product quantity
- 4,100 cases
- Termination date
- Aug 28, 2023
- Reason for recall
- Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Distribution pattern
- Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
- Recall initiation date
- Sep 21, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2018