Hemospray Endoscopic Hemostat Recall Due to Endoscope Adhesion Risk
Wilson-Cook Medical's Hemospray Endoscopic Hemostat is being recalled because the powder can adhere to the endoscope, potentially making it difficult to remove the instrument from the patient.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall without reported hospitalizations or injuries. The hazard is described as a potential risk of device adhesion leading to procedural complications. Per the recall severity rubric, risk-of-harm products without reported injuries are classified as High (score 3).
Plain-English summary
Wilson-Cook Medical Inc. is recalling Hemospray Endoscopic Hemostat devices (Reference Part Numbers HEMO-7, REF G56572; and HEMO-7-EU, REF G24663) used in endoscopic procedures. Approximately 63,830 units have been distributed throughout the United States and worldwide.
The recalled device is an endoscopic hemostat designed to control bleeding during endoscopic procedures. There is a potential risk that Hemospray powder may adhere to the distal end of the endoscope. This adhesion could cause the endoscope to stick to tissue, potentially resulting in difficulty or inability to maneuver or remove the endoscope during or after the procedure.
Healthcare facilities and medical providers should review their inventory for the affected devices using the UDI/DI codes (00827002565722 and 00827002246638) and all unexpired lot numbers. Contact Wilson-Cook Medical Inc. for information on product returns or corrective actions. Medical facilities should implement precautions when using remaining stock and have emergency protocols in place to address potential adhesion incidents during endoscopic procedures.
The recalled product
- Product
- Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
- Manufacturer
- Wilson-Cook Medical Inc.
- Affected units
- 63,830
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI : a) 00827002565722
- b) 00827002246638
- All unexpired lot numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Wilson-Cook Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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