Recall Z-2592-2015— Customed, Inc

Name: FDA recall Z-2592-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-10

Class II · Terminated

Class II FDA medical device recall by Customed, Inc, initiated 2015-07-10, terminated 2017-04-12. It names one FDA 510(k) clearance: K962652. Product: UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .. Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile..

Recalling firm: Customed, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-07-10
Terminated: 2017-04-12
Firm location: Fajardo, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)Customed, Inc.·cleared 1996-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Reason for recall

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Data sourced from openFDA. This site is unofficial and independent of the FDA.