Date Initiated by Firm |
July 23, 2002 |
Date Posted |
March 12, 2003 |
Recall Status1 |
Terminated 3 on January 24, 2005 |
Recall Number |
Z-0635-03 |
Recall Event ID |
25611 |
510(K)Number |
K945164
|
Product Classification |
Latex Patient Examination Glove - Product Code LYY
|
Product |
Latex examination gloves, Uniseal brand. |
Code Information |
Lot numbers: 41991221 41991223 41001105 41001120 41010428 41010530 41010613 41010618 |
Recalling Firm/ Manufacturer |
American Healthcare Products Inc 3260 Industry Drive Signal Hill CA 90806-4014
|
For Additional Information Contact |
Tony Dije 562-597-8995
|
Manufacturer Reason for Recall |
Unfit for intended use due to stickiness.
|
FDA Determined Cause 2 |
Other |
Action |
Firm sent recall letter 7/23/2002. |
Quantity in Commerce |
6121 cases |
Distribution |
Nationwide. |
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 = LYY and Original Applicant = PROTECTION GLOVES SDN. BHD.
|