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

  • 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 Recallsee related information
Date Initiated by FirmMay 02, 2019
Create DateJune 13, 2019
Recall Status1 Terminated 3 on August 23, 2019
Recall NumberZ-1780-2019
Recall Event ID 82910
Product Classification Accessories, catheter - Product Code KGZ
ProductNeff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Code Information lot 8373482
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
812-339-2235
Manufacturer Reason
for Recall		The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
FDA Determined
Cause 2		Under Investigation by firm
ActionUrgent Medical Device Recall notification letters dated 5/2/19 were sent to customers.
Quantity in Commerce97
DistributionNo distribution in the US. Products were distributed to the following foreign countries: China.
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.
-
-