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 1 Device Recall Nellcor CapnoProbe SLS1 sublingual Sensor

  • 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 1 Device Recall Nellcor CapnoProbe SLS1 sublingual Sensor see related information
Date Initiated by Firm August 24, 2004
Date Posted September 02, 2004
Recall Status1 Terminated 3 on December 15, 2005
Recall Number Z-1414-04
Recall Event ID 29892
510(K)Number K010795  
Product Classification Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - Product Code CCK
Product The probes involved have been part of the Nellcor¿ CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is in a sealed foil envelope. Each disposable probe is used only one time.
Code Information All lots of the CapnoProbe are under recall. Each unit has a code number printed on the packaging.
Recalling Firm/
Manufacturer		 Nellcor Puritan Bennett
4280 Hacienda Dr
Pleasanton CA 94588-2719
For Additional Information Contact James Bonds
800-635-5267 Ext. 3
Manufacturer Reason
for Recall		 The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis.
FDA Determined
Cause 2		 Other
Action On 8/24/04 the firm issued letters via Fax to all its direct consignees, informing them of the affected product and providing instructions on the recall. The firm followed up with phone calls to all consignees completed by 8/25/04. The firm also issued a press release via Associated Press on 8/27/04.
Quantity in Commerce 14,120 units
Distribution The firm has distributed the sensors to 1 researcher in Europe, and 68 to direct customers (medical facilities) and 112 Field Sales Reps. Currently, there are no finished goods at the manufacturing site. 655 cases of product were disposed of at the distribution facility due to product expiration. The firm estimates 442 cases (3,536 units) to be in distribution channels.
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 = CCK and Original Applicant = OPTICAL SENSORS, INC.
-
-