Recall Z-1412-2016— Customed, Inc

Name: FDA recall Z-1412-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-07

Class II · Terminated

Class II FDA medical device recall by Customed, Inc, initiated 2016-01-07, terminated 2017-05-03. It names one FDA 510(k) clearance: K962652. Product: Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY 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: 2016-01-07
Terminated: 2017-05-03
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

Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY 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.