FDAFDA · Food and drugs·Recall number Z-1237-2014
Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
Published March 26, 2014 · Recall initiated: February 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Convatec Inc.
- Distributor
- Worldwide Distribution and in the state of TX
- Lot
- 540204R001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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