Date Initiated by Firm | December 15, 2017 |
Date Posted | March 14, 2018 |
Recall Status1 |
Terminated 3 on July 18, 2019 |
Recall Number | Z-1194-2018 |
Recall Event ID |
79474 |
510(K)Number | K151513 |
Product Classification |
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
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Product | ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B |
Code Information |
Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019) |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
|
For Additional Information Contact | Elizabeth Norwood 866-246-6990 |
Manufacturer Reason for Recall | Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries. |
FDA Determined Cause 2 | Process control |
Action | Notification letters were sent to consignees with the following instructions: 1. If you have affected stock, quarantine so that the affected products can be
returned to Arrow.
2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to Arrow.
3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to Arrow. |
Quantity in Commerce | 305 |
Distribution | Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX. |
Total Product Life Cycle | TPLC Device Report |
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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 = FOZ
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