Public recall detail

Hemospray® Kit

2025-04-28

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Recall Safety notice
Quick summary

Quick summary: Hemospray® Kit. Date: 2025-04-28.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Hemospray® Kit. Date: 2025-04-28.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandWilson-Cook Medical Inc
ProductHemospray® Kit
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77347

Affected products

ProductHemospray® Kit
LotMore than 30 numbers, contact manufacturer.
ModelHEMO-10 HEMO-7
Serial numberMore than 30 numbers, contact manufacturer.
DescriptionHemospray® Kit

Issue

A limited number of nonconforming raw materials were manufactured into certain lot numbers of Hemospray® devices and distributed into the field. Use of the devices with these nonconforming raw materials may result in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated, prior to and during use, or after the procedure is complete. This can lead to the activation knob and carbon dioxide cartridge exiting the handle with force. Recall start date: November 4, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesWilson-Cook Medical, Inc. 4900 Bethania Station Rd., Winston Salem, North Carolina, United States, 27105
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77347
Background{}
CompaniesWilson-Cook Medical, Inc. 4900 Bethania Station Rd., Winston Salem, North Carolina, United States, 27105
AudiencesHealthcare
Source updated2025-04-28

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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