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Class 2 Device Recall Tegaderm |
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Date Initiated by Firm |
February 03, 2016 |
Create Date |
March 02, 2016 |
Recall Status1 |
Terminated 3 on June 28, 2016 |
Recall Number |
Z-1036-2016 |
Recall Event ID |
73237 |
Product Classification |
Dressing, wound, drug - Product Code FRO
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Product |
PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings |
Code Information |
Kit #73775, Lot 213403 |
Recalling Firm/ Manufacturer |
Medical Action Industries Inc 25 Heywood Rd Arden NC 28704-9302
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For Additional Information Contact |
Darcy Sisson 828-338-7557 Ext. 258
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Manufacturer Reason for Recall |
Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Medical Action Industries, Inc. sent an Urgent Medical Device Recall letter dated February 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine all product subject to this recall. Consignees were also instructed if product was further distributed to identify their consignees and notify them at once of this product recall. Recalled product should be returned to Medical Action Industries for credit or replacement by contacting quality@owens-minor.com . Consignees were asked to complete and return the enclosed response form. Consignees with questions were instructed to call 828-338-7630. |
Quantity in Commerce |
9 cases (180 kits) |
Distribution |
Nationwide distribution to MO, NE and TX . |
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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