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U.S. Department of Health and Human Services

Class 2 Device Recall Tegaderm

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 Class 2 Device Recall Tegadermsee related information
Date Initiated by FirmFebruary 03, 2016
Create DateMarch 02, 2016
Recall Status1 Terminated 3 on June 28, 2016
Recall NumberZ-1036-2016
Recall Event ID 73237
Product Classification Dressing, wound, drug - Product Code FRO
ProductPICC/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
FEI Number 1030451
Recalling Firm/
Manufacturer		 Medical Action Industries Inc
25 Heywood Rd
Arden NC 28704-9302
For Additional Information ContactDarcy Sisson
828-338-7557 Ext. 258
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
FDA Determined
Cause 2		Under Investigation by firm
ActionMedical 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 Commerce9 cases (180 kits)
DistributionNationwide distribution to MO, NE and TX .
Total Product Life CycleTPLC 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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