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 AbbVie PEG, PEG Kit 15FR

  • 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 AbbVie PEG, PEG Kit 15FR see related information
Date Initiated by Firm April 27, 2017
Create Date May 31, 2017
Recall Status1 Terminated 3 on July 09, 2019
Recall Number Z-2178-2017
Recall Event ID 77129
510(K)Number K142793  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Code Information Material/List number: 62918001 Lots: 32044225, 32155205, 32344326, 32461215   
Recalling Firm/
Manufacturer		 AbbVie Inc.
1 N Waukegan Rd
North Chicago IL 60064-1802
For Additional Information Contact AbbVie Medical Services
866-257-8292
Manufacturer Reason
for Recall		 PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
FDA Determined
Cause 2		 Under Investigation by firm
Action On April 27, 2017, firm sent letter (and response form) to customers, instructing them to inspect their inventory for affected lots and arrange a replacement kit to be delivered by AbbVie if a kit with missing components is discovered. Distributors were asked to notify their customers. Any returned affected product will be destroyed.
Quantity in Commerce 3,331 kits
Distribution Nationwide, Albania, Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Italy, Japan, Korea, Luxembourg, Netherlands, Norway, Portugal, Romania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey
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 = KNT and Original Applicant = AbbVie Inc.
-
-