| Date Initiated by Firm | June 07, 2017 |
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| Create Date | December 08, 2017 |
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| Recall Status1 |
Terminated 3 on April 25, 2019 |
| Recall Number | Z-0219-2018 |
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| Recall Event ID |
77661 |
| 510(K)Number | K142183 |
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| Product Classification |
Introducer, catheter - Product Code DYB
|
| Product | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY |
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| Code Information |
Lot 161110, 161214, 170119 |
Recalling Firm/
Manufacturer |
Terumo Medical Corp
2101 Cottontail Ln
Somerset NJ 08873-1277
|
| For Additional Information Contact |
908-302-4916 |
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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 |
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| 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. |
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| Distribution | Nationwide and Canada |
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| 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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| 510(K) Database | 510(K)s with Product Code = DYB
|
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