Convatec Inc.: Medical Device Recall in 2014 - (Recall #: Z-1236-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 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.

Product Classification:

Class II

Date Initiated: February 7, 2014

Date Posted: March 26, 2014

Recall Number: Z-1236-2014

Event ID: 67588

Reason for Recall:

The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

Status: Terminated

Product Quantity: 600 catheters

Code Information:

540204R001

Distribution Pattern:

Worldwide Distribution and in the state of TX

Voluntary or Mandated:

Voluntary: Firm initiated