FDAClass IIISeptember 19, 2012

BLOM-SINGER indwelling TEP Occluder recall

BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone…

Why was BLOM-SINGER indwelling TEP Occluder recalled?

Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.

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?

Lot#1008419

Product
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone…
Recalling firm
Helix Medical LLC
Quantity
2 devices
Distribution
Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
Recall date
September 19, 2012
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls