Date Initiated by Firm |
May 19, 2011 |
Date Posted |
June 22, 2011 |
Recall Status1 |
Terminated 3 on August 01, 2011 |
Recall Number |
Z-2575-2011 |
Recall Event ID |
58995 |
510(K)Number |
K960248
|
Product Classification |
PICC INSERTION TRAY - Product Code FMF
|
Product |
Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.
|
Code Information |
Lot/Serial Number(s): W1009188, W1009261, W1011070, W1101120, W1102014, W1103011 |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 311 Enterprise Dr Plainsboro NJ 08536-3344
|
For Additional Information Contact |
609-936-6824
|
Manufacturer Reason for Recall |
Kits contain protective wipes that may be contaminated with Bacillus cereus.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Integra LifeSciences consignees were notified by Urgent Medical Device Recall letter on May 20, 2011 and told to quarantine any remaining product and to notify customers to return any remaining product to them. Further information is available at (800) 241-2210. |
Quantity in Commerce |
520 kits |
Distribution |
UT |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = FMF and Original Applicant = PHYSICIAN INDUSTRIES, INC.
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