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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 02, 2019
Create Date June 13, 2019
Recall Status1 Terminated 3 on August 23, 2019
Recall Number Z-1780-2019
Recall Event ID 82910
Product Classification Accessories, catheter - Product Code KGZ
Product Neff 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 Contact Cook 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
Action Urgent Medical Device Recall notification letters dated 5/2/19 were sent to customers.
Quantity in Commerce 97
Distribution No distribution in the US. Products were distributed to the following foreign countries: China.
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.
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