Date Initiated by Firm |
June 07, 2017 |
Create Date |
December 08, 2017 |
Recall Status1 |
Terminated 3 on April 25, 2019 |
Recall Number |
Z-0216-2018 |
Recall Event ID |
77661 |
510(K)Number |
K142183
|
Product Classification |
Introducer, catheter - Product Code DYB
|
Product |
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY |
Code Information |
Lot 161111 |
Recalling Firm/ Manufacturer |
Terumo Medical Corp 2101 Cottontail Ln Somerset NJ 08873-1277
|
For Additional Information Contact |
908-302-4916
|
Manufacturer Reason for Recall |
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters (dated June 7, 2017) and Response Forms were sent to the consignees via UPS on June 7, 2017. |
Distribution |
Nationwide and Canada |
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 = DYB and Original Applicant = Terumo Medical Corporation
|