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U.S. Department of Health and Human Services

Class 2 Device Recall Merit Custom Kit

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  Class 2 Device Recall Merit Custom Kit see related information
Date Initiated by Firm November 10, 2020
Create Date December 29, 2020
Recall Status1 Terminated 3 on October 05, 2022
Recall Number Z-0749-2021
Recall Event ID 86831
Product Classification Angiography/angioplasty kit - Product Code OEQ
Product Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803

For Angiography/angioplasty.
The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze
Code Information (01)00884450255803  Lot # T1883210
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Merit Customer Service
801-208-4381
Manufacturer Reason
for Recall		 Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.
FDA Determined
Cause 2		 Packaging process control
Action On November 10, 2020, Merit Medical sent a "Urgent Product Recall Notice to affected consignees via FedEx mail In addition, to informing consignees about the recall issue, the firm ask consignees to take the following actions: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed Customer Response Form to Customer Service at response@merit.com within 10 days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. 6. If you have any questions concerning this communication, please dont hesitate to contact your Merit Sales Representative or Merit Customer Service at (801) 208-4381.
Quantity in Commerce 90 kits
Distribution US distribution to: KY, RI, and MD
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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