Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall OMRIX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall OMRIXsee related information
Date Initiated by FirmAugust 06, 2004
Date PostedSeptember 30, 2004
Recall Status1 Terminated 3 on October 29, 2004
Recall NumberZ-1497-04
Recall Event ID 29728
510(K)NumberK030032 
Product Classification Syringe, Piston - Product Code FMF
ProductCrosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, DC 20006, Manufactured by: Medimop Medical Projects Ltd, for OMRIX biopharmaceuticals, Utd, MDA blood bank, Sheba Hospital, Romat-Gan, PO8 888, Kiryat Ono 55000 Israel
Code Information Lot 0404 exp. Oct. 2008; Lot 0417 exp. Jan. 2009; Lot 0419 exp. Jan. 2009.
FEI Number 3003183625
Recalling Firm/
Manufacturer		 Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst.
Magen David Adom Blood Services Ctr.,
Sheba Hospital
Ramat Gan Israel
For Additional Information ContactRandolph L. Cooke
609-466-3512
Manufacturer Reason
for Recall		5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port .
FDA Determined
Cause 2		Other
ActionAmerican Red Cross was notified of the recall on July 25, 2004. Recall letter to the ARC direct accounts was sent out on 8/9/2004.
DistributionThe product was shipped from Israel to the American Red Cross distribution center in Louisville, KY. From there, the ARC would ship the product to other distributors and/or directly to 46 hospitals nationwide. There are no govt accounts.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMF
-
-