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Class 2 Device Recall Converters(R) Under Buttocks Drape with Fluid Control Pouch II, |
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Date Initiated by Firm |
June 27, 2017 |
Date Posted |
July 07, 2017 |
Recall Status1 |
Terminated 3 on March 29, 2019 |
Recall Number |
Z-2757-2017 |
Recall Event ID |
77686 |
Product Classification |
Drape, surgical - Product Code KKX
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Product |
Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. |
Code Information |
Lot 16LFS235, expires November 1, 2021 |
Recalling Firm/ Manufacturer |
Cardinal Health 200, LLC 1500 S Waukegan Rd Waukegan IL 60085-6728
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For Additional Information Contact |
Customer Advocacy 800-327-7503
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Manufacturer Reason for Recall |
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
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FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
Cardinal Health sent an Urgent Product Recall letter dated June 27, 2017, to all affected consignees. In the letter, the firm requested the following actions be taken:
1. Inspect your inventory for the affected product code and lot number (listed on the package)
2. segregate and quarantine all on-hand product
3. Return the enclosed acknowledgment form via fax to 847-689-9101 ir614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined or discarded.
4. Notify any customers to whom may have distributed or forwarded product affected by this product.
5. Contact the appropriate Customer Service group to arrange for return and credit of any affected product:
Hospital - 800-964-5227
Federal Government - 800-444-1166
Distributor - 600-635-6021
All other customers - 888-444-5401
For questions regarding this recall call 800-327-7503. |
Quantity in Commerce |
1591 each |
Distribution |
Worldwide Distribution - US (Nationwide including PR) and Canada |
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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