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 2 Device Recall Neptune waste management system

  • 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 2 Device Recall Neptune waste management system see related information
Date Initiated by Firm December 03, 2002
Date Posted February 01, 2003
Recall Status1 Terminated 3 on July 07, 2003
Recall Number Z-0524-03
Recall Event ID 25142
510(K)Number K012991  K990037  
Product Classification Apparatus, Exhaust, Surgical - Product Code FYD
Product Stryker brand Neptune waste management system; model 711-27-1.
Code Information All systems with a rover top cap assembly 711-27-001 manufactured from 1/1/01 to 12/31/01. The recalled caps can be visually distinguished because there is a flat lip where the lid connects to the unit, and the flat lip is covered by a metal retaining ring which holds the cap in place. Non-recalled units do not have a metal retaining ring, rather the caps are held in place by screws with ribs in the cap on either side of each screw.
Recalling Firm/
Manufacturer		 Stryker Instruments, Instruments Div.
4100 E. Milham
Kalamazoo MI 49001
Manufacturer Reason
for Recall		 Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.
FDA Determined
Cause 2		 Other
Action Each account was contacted by phone, beginning on December 3, 2002 and advised to refrain from using the units until repairs could be performed. A recall notification letter dated December 6, 2002 was sent to each account informing them of the recall and of plans for repairs.
Quantity in Commerce 370
Distribution United States
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 = FYD and Original Applicant = AMERICAN IMMUNO TECH
510(K)s with Product Code = FYD and Original Applicant = STRYKER INSTRUMENTS
-
-