FDAClass IIApril 18, 2018

Rectal Catheters recall

Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the…

Why was Rectal Catheters recalled?

These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch Numbers: 13DE17 13EE22 13FE24 13FE26 13GE28 13GE29 13GE31 13KE47 13LE49 14AE03 14AE04 14FE25 14GE27 14HE32 14HE33 14HE35 14IE37 14IE38 14LE49 15AE05 15BE08 15CE13 15DE15 15DE16 15DE17 15DE18 15FE23 15FE25 15FE26 15GE27 15GE28 15GE29 15GE30 15HE32

Product
Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the…
Recalling firm
Teleflex Medical Europe Ltd
Quantity
6340 units
Distribution
US Nationwide Distribution
Recall date
April 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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