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 Karl Storz

  • 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 Karl Storzsee related information
Date Initiated by FirmFebruary 29, 2016
Create DateOctober 02, 2018
Recall Status1 Terminated 3 on September 28, 2016
Recall NumberZ-1333-2016
Recall Event ID 72921
Product Classification Accessories, cleaning brushes, for endoscope - Product Code MNL
ProductENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
Code Information All lot numbers
FEI Number 1221826
Recalling Firm/
Manufacturer		 Karl Storz Endovision, Inc.
91 Carpenter Hill Rd
Charlton MA 01507-5274
For Additional Information ContactSAME
508-248-9011
Manufacturer Reason
for Recall		Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel of the intended endoscope or to completely pass it through such channel.
FDA Determined
Cause 2		Component design/selection
ActionKarl Storz issued Recall Letter to users on 12/23/15. Firm's letter: KARL STORZ has identified a replacement brush; model 11276CL2 that is now available to clean your endoscope. Please check your inventory and remove any model 11276CL brushes. These brushes must be returned to KARL STORZ. Please complete the attached form and followthe return instructions. Upon receipt of any 11276CL brushes from you we will provide you the 11276CL2 cleaning brush as replacement at no charge. Contact Lynn Carter, Director Quality Assurance at 508-248-9011, extension 1664 Monday through Friday, 8:00AM to 4:30PM, Eastern Time.
Quantity in Commerce16908 brushes
DistributionNationwide Foreign: Canada, Mexico,
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.
-
-