Customed, Inc: Medical Device Recall in 2015 - (Recall #: Z-2590-2015)

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:

LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and 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-2590-2015

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: 1072

Code Information:

Code:900149 Lots: 140814945 exp. 10/31/16 140814945 exp. 10/31/16 141015802 exp. 11/30/15 141216410 exp. 1/31/16 141216410 exp. 1/31/16 150217444 exp. 2/28/16 150217446 exp. 2/28/16 150217445 exp. 2/28/16 150217445 exp. 2/28/16 150317607 exp. 3/31/16 150317605 exp. 3/31/16 150317606 exp. 3/31/16 150317608 exp. 3/31/16 150317609 exp. 3/31/16

Distribution Pattern:

Distributed Only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated