Recall Z-0068-2012 ยท KGT Drape, Adhesive, Aerosol
Kapp Surgical Instrument Inc
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.
| Date | Oct 19, 2011 (initiated Mar 5, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.