Recall Z-2548-2015— Customed, Inc

Name: FDA recall Z-2548-2015
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: K904694. Product: ANGIODRAPE PK 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

K904694 — CUSTOMED ANGIODRAPE PACK FEMORALCustomed, Inc.·cleared 1991-01-02

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

ANGIODRAPE PK 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.