FDAClass IISeptember 14, 2016

WECK¿ Horizon" Manual-Load Ligating Clip Applier recall

WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product…

Why was WECK¿ Horizon" Manual-Load Ligating Clip Applier recalled?

Misbranded: Incorrect etching on the device.

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?

Product Code: 337111, Lot Number: 06F1515745.

Product
WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product…
Recalling firm
Teleflex Medical
Quantity
49 units
Distribution
Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.
Recall date
September 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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