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U.S. Department of Health and Human Services

Class 2 Device Recall HydroSil Gripper Intermittent Catheters

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  Class 2 Device Recall HydroSil Gripper Intermittent Catheters see related information
Date Initiated by Firm September 14, 2017
Date Posted April 04, 2018
Recall Status1 Terminated 3 on November 05, 2019
Recall Number Z-1307-2018
Recall Event ID 78642
510(K)Number K000723  K122785  
Product Classification Catheter, straight - Product Code EZD
Product HydroSil 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 Contact BMD 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
Action A 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 Commerce 44640.0 units
Distribution US 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 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 = EZD and Original Applicant = ROCHESTER MEDICAL CORP.
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