| Class 2 Device Recall Henora | |
Date Initiated by Firm | March 28, 2014 |
Date Posted | July 07, 2014 |
Recall Status1 |
Terminated 3 on September 29, 2016 |
Recall Number | Z-1996-2014 |
Recall Event ID |
68552 |
510(K)Number | K001599 |
Product Classification |
Set, administration, intravascular - Product Code FPA
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Product | Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set
Product Usage:
Catheter extension set for high pressure procedures. |
Code Information |
Lot numbers 102131 and 110531. |
Recalling Firm/ Manufacturer |
RGI Medical Manufacturing, Inc. 4637 NW 6th St Gainesville FL 32609-0701
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For Additional Information Contact | Jesse Bishop 352-378-3633 |
Manufacturer Reason for Recall | Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use. |
FDA Determined Cause 2 | Process control |
Action | RGI Medical Manufacturing, Inc. phoned their direct account: Baxter Healthcare on February 28, 2014 and sent an Urgent: Device Recall letter dated March 21, 2014. The letter identified the affected product, problem and the actions to be taken. Contact 800-747-6870 to obtain instruction for returning the product to RGI |
Quantity in Commerce | 19,200 units. |
Distribution | US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI. |
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 = FPA
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