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 HydroSil Gripper Intermittent Catheters

  • 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 HydroSil Gripper Intermittent Catheterssee related information
Date Initiated by FirmSeptember 14, 2017
Date PostedApril 04, 2018
Recall Status1 Terminated 3 on November 05, 2019
Recall NumberZ-1307-2018
Recall Event ID 78642
510(K)NumberK000723 K122785 
Product Classification Catheter, straight - Product Code EZD
ProductHydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
Code Information Item 50610 Lots #'s: JUBT0404, JUBP0700, JUBR2498, JUBS1289
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information ContactBMD Recall Coordinator
800-793-8110
Manufacturer Reason
for Recall		Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
FDA Determined
Cause 2		Process control
ActionA notification letter was sent to four hundred and fourteen (414) consignees via Federal Express on September 15, 2017. The letter explained the problem and requested return of the product. Distributors were directed to cease distribution of the recalled products and notify their customers of the recall.
Quantity in Commerce44640.0 units
DistributionUS Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, HI, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Puerto Rico
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 = EZD
-
-