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 Pump Tube

  • 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 Pump Tubesee related information
Date Initiated by FirmFebruary 02, 2004
Date PostedFebruary 11, 2004
Recall Status1 Terminated 3 on March 24, 2004
Recall NumberZ-0537-04
Recall Event ID 28227
510(K)NumberK011911 
Product Classification Catheter And Tip, Suction - Product Code JOL
ProductPump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter stones; Richard Wolf GmbH, D-75438 Knittlingen Germany
Code Information part number 8170.121  There is no lot number or production code.
Recalling Firm/
Manufacturer		 Richard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy
Vernon Hills IL 60061-3110
For Additional Information ContactMr. Robert L. Casarsa
800-323-9653
Manufacturer Reason
for Recall		If the drain tube is assembled incorrectly, the suction pump will not operate as intended.
FDA Determined
Cause 2		Other
ActionThe accounts were telephoned on 2/2/04 and informed of the potential to re-assemble the suction pump drain tubing incorrectly after sterilization. The accounts were sent re-designed replacement tubing sets and were requested to return the old tubing sets to Richard Wolf.
Quantity in Commerce2 tube sets
DistributionTexas and Nebraska
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JOL
-
-