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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Kapp Surgical Instrument Inc
Lot Codes / Batch Numbers
Model #SC5000-4R, Lot #090710, Expiration Date: 2009-10
Products Sold
Model #SC5000-4R, Lot #090710, Expiration Date: 2009-10
Kapp Surgical Instrument Inc is recalling STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesiv due to A portion of the labeled expiration date is missing. The expiration date on approximately half of the pouch labels distributed are missing the last di. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026