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

FDA device recall Z-0068-2012 · posted 2011-10-19 · Terminated

Recall details

Recalling firm

Kapp Surgical Instrument Inc

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.

Action taken

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.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

KGT

Quantity affected

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

Date initiated

2008-03-05

Date posted

2011-10-19

Date terminated

2013-02-19

Location

Warrensville Heights, OH