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U.S. Department of Health and Human Services

Class 3 Device Recall MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz

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  Class 3 Device Recall MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz see related information
Date Initiated by Firm December 16, 2011
Create Date June 26, 2015
Recall Status1 Terminated 3 on July 27, 2012
Recall Number Z-0694-2012
Recall Event ID 60851
510(K)Number K970370  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory.

The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin.
Code Information Lot #1029402
Recalling Firm/
Manufacturer		 Merz Aesthetics, Inc.
4133 Courtney Rd Ste 10
Franksville WI 53126-9127
For Additional Information Contact
262-286-4025
Manufacturer Reason
for Recall		 Merz Aesthetics is initiating a medical device recall on TSK Closed Tip Cannula (27GA x 25mm) due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25 mm in size instead of 27G x 38 mm. Length of the cannula is a matter of user preference and is unlikely to impact patient safety.
FDA Determined
Cause 2		 Packaging process control
Action Merz Aesthetics Inc, initially contacted customers by telephone on December 16, 2011. They were informed that the wrong size cannula were sent with their last order and would need to be returned and a replacement order would be sent. . Merz Aesthetics sent a "Urgent Medical Device Recall" letter dated January 6, 2012. The letter identified the product the problem and the action needed to be taken by the customer. In addition, if you have further distributed this product, please identify your customers and notify them of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. You may contact Merz Aesthetics Customer Service at (866) 862-1211 or (262) 835- 3333 ,for instructions regarding the return and immediate replacement of the product, or if you have any further questions or concerns..
Quantity in Commerce 5 boxes (20 units per box)
Distribution Nationwide Distribution including the states of CA, NY, OK, and TN.
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.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = TSK LABORATORY, JAPAN
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