Date Initiated by Firm |
October 17, 2007 |
Date Posted |
March 26, 2008 |
Recall Status1 |
Terminated 3 on May 14, 2008 |
Recall Number |
Z-1298-2008 |
Recall Event ID |
46780 |
510(K)Number |
K052735
|
Product Classification |
Acellular Matrix with Demineralized Bone - Product Code MQV
|
Product |
AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine |
Code Information |
Lot Numbers: B07F25I; Exp 4/2009; B07F25J: Exp 4/2009; and B07425H; Exp 3/2009. |
Recalling Firm/ Manufacturer |
LifeCell Corporation 1 Millennium Way Somerville NJ 08876-3876
|
For Additional Information Contact |
Bonnie Samuel 908-947-1042
|
Manufacturer Reason for Recall |
Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reactive for both Hepatitis B Surface Antigen and Hepatitis B Core IgM/IgG Antibody)
|
FDA Determined Cause 2 |
Release of Material/Component prior to receiving test results |
Action |
Consignee was notified by telephone, followed by a Recall letter sent by FAX on October 17, 2007 requesting return of any unused product. |
Quantity in Commerce |
46 kits |
Distribution |
All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ. |
Total Product Life Cycle |
TPLC Device Report
|
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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) Database |
510(K)s with Product Code = MQV and Original Applicant = LIFECELL CORP.
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