FDAClass IIMarch 2, 2016

Auto Endo5 Hem-o-lok Automatic Clip Applier recall

Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML…

Why was Auto Endo5 Hem-o-lok Automatic Clip Applier recalled?

The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application.

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?

73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565, 73J1500566, 73K1500193

Product
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML…
Recalling firm
Teleflex Medical
Quantity
543 ea.
Distribution
Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium
Recall date
March 2, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls