Customed, Inc: Medical Device Recall in 2015 - (Recall #: Z-2549-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Product Classification:

Class II

Date Initiated: July 10, 2015

Date Posted: September 9, 2015

Recall Number: Z-2549-2015

Event ID: 71721

Reason for Recall:

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

Status: Terminated

Product Quantity: 20200 kits

Code Information:

Catalog number: 900010 Lots: 141015851 exp. 10/31/2015 150116710 exp.1/31/2016 150117001 exp.2/28/2016 150317560 exp.3/31/2016 150317560 exp.3/31/2016 150418252 exp.5/31/2016 150418252 exp.5/31/2016 150518605 exp.5/31/2016 150518605 exp.5/31/2016

Distribution Pattern:

Distributed Only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated