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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmFebruary 07, 2014
Date PostedMarch 20, 2014
Recall Status1 Terminated 3 on December 18, 2014
Recall NumberZ-1236-2014
Recall Event ID 67588
Product Classification Catheter, urological - Product Code KOD
ProductMedline 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.
Code Information 540204R001
Recalling Firm/
Manufacturer		 Convatec Inc.
200 Headquarters Park Dr
Skillman NJ 08558-2600
For Additional Information ContactMr. Greg Kowzun
908-904-2675
Manufacturer Reason
for Recall		The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
FDA Determined
Cause 2		Device Design
ActionConvatec 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.
Quantity in Commerce600 catheters
DistributionWorldwide Distribution and in the state of TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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