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U.S. Department of Health and Human Services

Class 2 Device Recall Invia Wound Therapy Tier I Wound Dressing Kit, 10 MM Flat Drain

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  Class 2 Device Recall Invia Wound Therapy Tier I Wound Dressing Kit, 10 MM Flat Drain see related information
Date Initiated by Firm July 27, 2011
Date Posted September 08, 2011
Recall Status1 Terminated 3 on February 16, 2012
Recall Number Z-3172-2011
Recall Event ID 59453
510(K)Number K080357  
Product Classification Wound Dressing Kit - Product Code MCY
Product Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061.
Medela Healthcare,
McHenry, IL 60051;

A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case;

Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118

Code Information product code 0877061, lot 370118, some of which were mislabeled as product 0877067, lot 370118
Recalling Firm/
Manufacturer
Medela Inc
1101 Corporate Dr
Mchenry IL 60050-7006
For Additional Information Contact Mr. Donald J. Alexander
815-578-2406
Manufacturer Reason
for Recall
Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain", were labeled incorrectly as "0877067 Wound Dressing Set, Tier III 15 Fr Round Channel Drain". The outside label on the case is correctly labeled as "0877061 Wound Dressing Set, Tier 1,10 MM Flat Drain".
FDA Determined
Cause 2
Error in labeling
Action Medela Inc. sent an "Urgent Device Recall" letter dated July 26, 2011 to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) not to use the affected lot and place them in quarantine 2) stop sale and distribution and set aside their existing inventory of the affected product 3) conduct a physical count and record the data on the Product Inventory Form included with this letter 4) complete and return the Product Inventory Form via fax to 800-995-7867 or e-mail suction@medela.com, even if they have no affected product on hand 5)if they have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. 6) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots. If you have any questions about this recall please call (877) 735-1626 or e-mail at suction@medela.com.
Quantity in Commerce 3,000 kits
Distribution Nationwide Distribution including the states of California, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee and Texas.
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 = MCY and Original Applicant = MEDELA AG
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