Wilson-Cook Medical Recalls Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostats
Wilson-Cook Medical is recalling specific lots of Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostats because they were manufactured with nonconforming raw materials.
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 used for hemostasis where nonconforming raw materials could lead to a risk of harm, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Wilson-Cook Medical Inc. is recalling specific lots of Cook Medical Hemo-7 Hemospray Endoscopic Hemostat (REF G56572) and Hemo-10 Hemospray Endoscopic Hemostat (REF G21049). These devices are used for the hemostasis of nonvariceal gastrointestinal bleeding. The recall involves 4,605 devices.
The recall was initiated because specific lots of the product were manufactured with nonconforming raw materials. The affected devices were distributed nationwide, including to government and military facilities, as well as to foreign countries including Canada, Costa Rica, Guatemala, and numerous other nations.
Healthcare facilities and consumers should stop using the affected devices and contact Wilson-Cook Medical for instructions on how to return or dispose of them. The specific lot numbers and expiration dates are listed in the official FDA recall notice.
The recalled product
- Product
- Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
- Manufacturer
- Wilson-Cook Medical Inc.
- Hazard
- Affected units
- 4,605
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 (20)
- HEMO-7
- REF G56572 - UDI-DI 00827002565722
- Lot numbers: W4849600
- exp. 6/27/2027
- W4849968
- exp. 6/28/2027
- W4849969
- W4849970
- W4849971
- W4849972
- W4850219
- exp. 7/1/2027
- W4850220
- W4850221
- W4850659
- exp. 7/2/2027
- W4850660
- W4850662
- W4851084
- exp. 7/3/2027
Distribution
Distributed nationwide across the United States.
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