Z-0068-2012

STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive...

Name: Z-0068-2012 STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive...
Creator: Kapp Surgical Instrument Inc
Published: 2008-03-05
License: https://open.fda.gov/license/

Kapp Surgical GmbH / initiated 2008-03-05 / Terminated / root cause: labeling and UDI

FDA source

Kapp Surgical Instrument Inc began a recall of 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... on 2008-03-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0068-2012
Status: Terminated
Initiated: 2008-03-05
Posted: 2011-10-19
Terminated: 2013-02-19
Recalling firm: Kapp Surgical GmbH
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.
Product code: KGT Drape, Adhesive, Aerosol
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.
Root cause tag: labeling and UDI
FDA 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 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
Product codes and lots: Model #SC5000-4R, Lot #090710, Expiration Date: 2009-10

Product code KGT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)