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Class 2 Device Recall Dermacea Gauze Fluff Roll |
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Date Initiated by Firm |
August 01, 2018 |
Create Date |
October 03, 2018 |
Recall Status1 |
Terminated 3 on June 03, 2020 |
Recall Number |
Z-0017-2019 |
Recall Event ID |
80924 |
510(K)Number |
K990530
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Product Classification |
Dressing, wound, occlusive - Product Code NAD
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Product |
Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. |
Code Information |
Lot Numbers: 18D180662,18E070362,18E222362,18F072362 |
Recalling Firm/ Manufacturer |
COVIDIEN LLC 15 Hampshire St Mansfield MA 02048-1113
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For Additional Information Contact |
508-261-8000
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Manufacturer Reason for Recall |
Potential for product sterility breach due to a compromised or pinched seal defect
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
On August 1, 2018 Cardinal Health issued Urgent Medical Device Recall notices to U.S. customers via Fed Ex and OUS customers were directly contacted by Quality & Regulatory Affair representatives supporting that country. Customers were advised to take the following actions:
1. Inspect stock and quarantine affected product.
2. Immediately stop using affected product.
3. Return the completed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from customers, and to prevent further notices.
4. Notify any customers to whom you may have distributed product affected by this recall.
5. Contact the appropriate Customer Service group to arrange for credit and return of any affected product you may have:
¿ Hospital 800-964-5227
¿ Federal Government 800-444-1166
¿ Distributors800-635-6021
¿ All other customers 888-444-5440
Customers with any questions regarding this letter may call (800) 292-9332. |
Quantity in Commerce |
2,730,821 units in total |
Distribution |
US Nationwide Distribution |
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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510(K) Database |
510(K)s with Product Code = NAD and Original Applicant = THE KENDALL COMPANY, L.P.
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