FDAClass IIJuly 10, 2013

-ENDOPATH ETS-Flex Articulating Endoscopic Linear recall: Sterility Concern

-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small…

Why was -ENDOPATH ETS-Flex Articulating Endoscopic Linear recalled?

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

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?

122300, 123263, 122490, 122753, 122406, 122675, 122309

Product
-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small…
Recalling firm
Surgical Instrument Service And Savings, Inc.
Quantity
13
Distribution
Nationwide Distribution.
Recall date
July 10, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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