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U.S. Department of Health and Human Services

Medical Devices

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Ethicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin

Recall Class: Class I

Date Recall Initiated: August 21, 2012

Products :

SURGIFLO Hemostatic Matrix (Product Code: 2991)

  • Lot # 239091 Exp Mar-13
  • Lot # 238783 Exp Sep-13
  • Lot # 238635 Exp Mar-13
  • Lot # 237498 Exp Mar-13
  • Lot # 237119 Exp Mar-13
  • Lot # 235488 Exp Jan-13

SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin (Product Code 2993)

  • Lot # 239346 Exp Jan-13
  • Lot # 239411 Exp Jun-13

These products were manufactured from September 16, 2011 through July 27, 2012 and distributed from September 29, 2011 through August 7, 2012.

Use: 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.

Recalling Firm:
Ethicon, Inc.
US Highway 22 West
Sommerville, New Jersey 08876

Reason for Recall: There is an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. This product may cause serious adverse health consequences, including death.

Public Contact: For questions regarding this recall, please call Ethicon at 1-877-384-4266.

FDA District: New Jersey District Office

FDA Comments:

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. Affected products should be returned for replacement to Stericycle using the enclosed pre-paid shipping label.

Customers with questions should call 1-877-384-4266 or contact their Ethicon Biosurgery Sales Representative.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.