Wilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Misassembly
Wilson-Cook Medical Inc. is recalling 160 units of Hemospray Endoscopic Hemostat because misassembly may prevent the device from spraying powder.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves a medical device failing to perform its intended function (spraying powder) during a procedure, which poses a risk of harm without reported injuries.
Plain-English summary
Wilson-Cook Medical Inc. is recalling 160 units of the Hemospray Endoscopic Hemostat. The recall is due to a potential misassembly issue that could prevent the device from spraying powder as intended.
The affected devices include model numbers HEMO-10, HEMO-10-EU, and HEMO-7-EU. Specific lot codes involved are W4179646, W4180858, W4180861, W4181073, W4180860, W4181071, W4189223, and W4189224. The FDA has classified this as a Class II recall.
The devices were distributed nationwide to 20 U.S. states, including California, Colorado, Connecticut, Florida, Illinois, Indiana, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Dakota, Texas, Virginia, and Washington. International distribution included Canada, Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Italy, Portugal, Spain, and the United Kingdom. Healthcare providers should check their inventory for these specific model and lot numbers and stop using the affected units.
The recalled product
- Product
- Hemospray Endoscopic Hemostat
- Manufacturer
- Wilson-Cook Medical Inc.
- Affected units
- 160
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 (11)
- Model Numbers: HEMO-10
- HEMO-10-EU
- HEMO-7-EU
- Lot Codes: W4179646
- W4180858
- W4180861
- W4181073
- W4180860
- W4181071
- W4189223
- W4189224
Distribution
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