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Terminated

SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc 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.

FDA Recall Z-1241-2014 · Posted 2014-03-20

Recalling FirmConvatec Inc.
Recall StatusTerminated
Product CodeKOD
Date Initiated2014-02-07
Date Terminated2014-12-18
Product Quantity4,760 catheters

Reason for Recall

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

Firm Action

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

Distribution Pattern

Worldwide Distribution and in the state of TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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