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U.S. Department of Health and Human Services

Class 3 Device Recall STRIP T'S Sterile Adhesive Organizer

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  Class 3 Device Recall STRIP T'S Sterile Adhesive Organizer see related information
Date Initiated by Firm March 05, 2008
Date Posted October 19, 2011
Recall Status1 Terminated 3 on February 19, 2013
Recall Number Z-0068-2012
Recall Event ID 60000
Product Classification Drape, adhesive, aerosol - Product Code KGT
Product STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'. The shelf box is placed into a shipping container.

The Sterile Adhesive Organizer is used to hold tubing or instruments to the drape in surgery.
Code Information Model #SC5000-4R, Lot #090710, Expiration Date: 2009-10
Recalling Firm/
Manufacturer		 Kapp Surgical Instrument Inc
4919 Warrensville Center Rd
Warrensville Heights OH 44128-4353
For Additional Information Contact
216-587-4400
Manufacturer Reason
for Recall		 A portion of the labeled expiration date is missing. The expiration date on approximately half of the pouch labels distributed are missing the last digit of the year of expiration. However, the shelf box containing the pouches is labeled correctly.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Surgical Concepts, Inc ( A subsidiary of Kapp Surgical Instrument Inc) sent a notification letter dated March 5, 2008, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm ceased distribution of the suspect product on December 5, 2007. The letter informs the firm's customers (both distributors and medical user/customers) of the expiration date labeling omission of the last digit of the year of expiration. It goes on to explain that the incomplete expiration date is present on the individual packages only and that the shelf boxes are labeled correctly with the complete/correct expiration date. The letter provides the customers with a contact person and a toll free telephone number 1-(800) 282-5277, to call in order to make arrangements for receive replacement labels for any misbranded packages received.
Quantity in Commerce 59 boxes (3540 units)
Distribution Nationwide Distribution-- including the states of AK, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MT, NC, NM, OH, PA, TN, TX, UT, and VA
Total Product Life Cycle TPLC 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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