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Ethicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin: Class I Recall - Potential for Packaging Breach
AUDIENCE: Risk Manager, Surgery
ISSUE: There is an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. These products were manufactured from September 16, 2011 through July 27, 2012 and distributed from September 29, 2011 through August 7, 2012. Read the Recall Notice for a list of affected lot numbers.
This product may cause serious adverse health consequences, including death.
BACKGROUND: SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is used in surgical procedures (other than ophthalmic) as an aide to stop the flow of bleeding (hemostasis) when controlling bleeding by use of a suture (ligature) or when other conventional methods are ineffective or impractical.
SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) as an aide to stop the flow of bleeding ( hemostasis), when controlling capillary, venous and arterial bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. This is a topical, absorbable hemostat consisting of a paste (flowable gelatin matrix) and a freeze-dried (lyophilized) Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery.
RECOMMENDATION: Ethicon Inc. sent an Urgent Product Information letter dated August 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Ethicon instructed customers to inspect their inventory to determine if they have any of the affected products.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Recall Notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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