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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion Port Access Dressing Change Tray

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 Class 2 Device Recall Centurion Port Access Dressing Change Traysee related information
Date Initiated by FirmMarch 16, 2010
Date PostedJune 30, 2010
Recall Status1 Terminated 3 on February 09, 2011
Recall NumberZ-1936-2010
Recall Event ID 55885
Product Classification Start/Stop Dialysis Tray - Product Code FKG
ProductDialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI
Code Information 905058, 902188, 902118, 2008101390, 2008110390, 2008120190, 2009011990, 2009012690, 2009021690, 2009040690, 2009051190, 2009060190, 2009062990, 2009072790, 2009101290, 2009110290 and 2010011890.
Recalling Firm/
Manufacturer		 Centurion Medical Products
301 Catrell Dr
Howell MI 48843-1703
For Additional Information Contact
517-546-5400
Manufacturer Reason
for Recall		The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged.
FDA Determined
Cause 2		Other
ActionThe firm sent Urgent Recall Product Notices to its two customers dated 3/16/2010. The letter explained that the tape may not adhere properly. The consignees were instructed to remove any kits containing the recalled tape from their inventory, if the tape was used to secure dialysis needles or pressure dressings. If the tape was used for other purposes, the kits could still be used. The recall letter included a reply form for customers to complete and email or fax back. Upon receipt of the form, a Centurion Representative will contact them to retrieve affected product. Customers should contact Matthew Price at 517-546-5400 ext. 1135, if further info is needed.
Quantity in Commerce3144 kits
DistributionNationwide Distribution -- AR and OH.
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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