| Date Initiated by Firm | September 29, 2009 |
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| Date Posted | December 14, 2009 |
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| Recall Status1 |
Terminated 3 on December 15, 2009 |
| Recall Number | Z-0512-2010 |
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| Recall Event ID |
53557 |
| 510(K)Number | K884913 |
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| Product Classification |
Inflation Syringe - Product Code DXT
|
| Product | Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: MONARCH CATALOG NUMBER IN2130 for inflation and deflation of interventional devices |
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| Code Information |
Lot # F730935 |
Recalling Firm/
Manufacturer |
Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095
|
| For Additional Information Contact |
801-253-1600 |
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Manufacturer Reason
for Recall | Potential sterility breach caused by excessive shipment damage. |
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FDA Determined
Cause 2 | Other |
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| Action | Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365. |
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| Quantity in Commerce | 5 inflation syringes |
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| Distribution | US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution. |
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| 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 = DXT
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