Date Initiated by Firm | June 12, 2017 |
Date Posted | June 27, 2017 |
Recall Status1 |
Terminated 3 on September 06, 2018 |
Recall Number | Z-2698-2017 |
Recall Event ID |
77604 |
510(K)Number | K112896 |
Product Classification |
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
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Product | Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology |
Code Information |
Device Listing # D149129 Material # ASK-45552-RWJ4 PR-45552-HPHNL |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
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For Additional Information Contact | 610-378-0131 |
Manufacturer Reason for Recall | Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.
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FDA Determined Cause 2 | Device Design |
Action | Teleflex/Arrow International mailed an Urgent Medical Device Recall Notification Letter to affected customers on 06/12/2017 to inform them of the issue. Arrow requested that customers examine their inventory immediately for the affected lots and discontinue use and quarantine any products with the associated product codes identified in the notice and complete the Recall Acknowledgement Form and fax back to the number included in the notice. |
Quantity in Commerce | 9,037 units in the U.S. and 4,500 units internationally |
Distribution | Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok |
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 = LJS
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