FDAClass IISeptember 25, 2019

Hemospray Endoscopic Hemostat recall

Hemospray Endoscopic Hemostat

Why was Hemospray Endoscopic Hemostat recalled?

Potential for Hemospray device to be unable to spray powder due to misassembly of devices.

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?

Model Numbers: HEMO-10, HEMO-10-EU, HEMO-7-EU; Lot Codes: W4179646, W4180858, W4180861, W4181073, W4180860, W4181071, W4189223, W4189224

Product
Hemospray Endoscopic Hemostat
Recalling firm
Wilson-Cook Medical Inc.
Quantity
160 units
Distribution
Nationwide distribution to CA, CO, CT, FL, IL, IN, KY, LA, MN, MO, NC, NJ, NY, OH, PA, RI, SD, TX, VA, WA. International distribution to Canada, Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Italy, Portugal, Spain, and United Kingdom.
Recall date
September 25, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls