SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The

FDA device recall Z-1238-2014 · posted 2014-03-20 · Terminated

Recall details

Recalling firm

Convatec Inc.

Reason for recall

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

Action taken

Convatec sent Urgent: Voluntary Medical Device Recall letters dated 2/7/2014 via UPS and email. Foreign customers were provided the notice via DHL. The letter identified the affected product, problem and actions to be taken. Customers are asked to perform a count of recalled product in inventory. All consignees should be contacted and be instructed to return product based on their procedures. Customers were instructed to complete and return the enclosed respoonse form.

Root cause

Device Design

Status

Terminated

Product code

KOD

Quantity affected

5,540 catheters

Distribution

Worldwide Distribution and in the state of TX

Date initiated

2014-02-07

Date posted

2014-03-20

Date terminated

2014-12-18

Location

Skillman, NJ