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 CBC II Wound Drains

  • 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 CBC II Wound Drains see related information
Date Initiated by Firm March 26, 2015
Date Posted May 01, 2015
Recall Status1 Terminated 3 on December 31, 2015
Recall Number Z-1573-2015
Recall Event ID 70841
510(K)Number K970714  
Product Classification Apparatus, autotransfusion - Product Code CAC
Product Ambulating Bulb

Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage.
Code Information Part Number:0225-028-852 and lot numbers: 10097012 10281012 11087012 11178012 12066012 12335012 13234012 14178012 10105012 10298012 11095012 11189012 12101012 12348012 13248012 14197012 10130012 10312012 11105012 11206012 12108012 12353012 13263012 14254012 10162012 10322012 11115012 11229012 12138012 13046012 13302012 14260012 10172012 10337012 11130012 11269012 12156012 13086012 13319012 10195012 10340012 11139012 11313012 12159012 13095012 14029012 10205012 11003012 11146012 11337012 12199012 13108012 14052012 10238012 11013012 11147012 12016012 12248012 13143012 14058012 10251012 11048012 11151012 12040012 12261012 13171012 14155012 10272012 11055012 11160012 12041012 12289012 13221012 14164012 
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Angela Ragainis
269-323-7700
Manufacturer Reason
for Recall		 Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
FDA Determined
Cause 2		 Package design/selection
Action An URGENT MEDICAL DEVICE NOTIFICATION letter was sent to all customers on 03/31/2015. The letter identified the affected product, the reason for the recall, the risk to health, and actions to be taken by the customer or user. All are asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers were asked to immediately check all inventory and quarantine any affected product, return affected product to Stericycle for destruction using a return label provided by Stericycle. Upon receipt of affected product a credit will be issued to customer account.
Quantity in Commerce 2,575 boxes (25,750 each)
Distribution Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
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 = CAC and Original Applicant = STRYKER INSTRUMENTS
-
-