Device product
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x 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.
Z-1240-2014
Product summary
- Firm
- Convatec Inc.
- Event
- Event 67588
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54,590 catheters
- Official record key
device-enforcement:Z-1240-2014
Official wording
Reason: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Code information: 540204R001
Distribution pattern: Worldwide Distribution and in the state of TX
Derived failure modes
-
Unknown
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.