Customed, Inc: Medical Device Recall in 2015 - (Recall #: Z-2657-2015)

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 SURGICAL PACK 3/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-2657-2015

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: 1866

Code Information:

Code:900281A Lots: 140814951 exp. 2/28/16 140714543 exp. 2/28/16 141015713 exp. 10/31/15 150116503 exp. 12/31/15 150116513 exp. 12/31/15 150116514 exp. 12/31/15 150116515 exp. 12/31/15 141216437 exp. 12/31/15 150116939 exp. 2/28/16 150116940 exp. 2/28/16 150116938 exp. 2/28/16 150116941 exp. 2/28/16 150116937 exp. 2/28/16 150317732 exp. 3/31/16 150317731 exp. 3/3/16 150317734 exp. 3/31/16 150317733 exp. 3/31/16 150317954 exp. 4/30/16 150317957 exp. 4/30/16 150317958 exp. 4/30/16 150317959 exp. 4/30/16 150317960 exp. 4/30/16 150317961 exp. 4/30/16 150418383 exp. 4/30/16 150418384 exp. 4/30/16 150418385 exp. 4/30/16 150518790 exp. 5/31/16 150519028 exp. 5/31/16 150519029 exp. 5/31/16

Distribution Pattern:

Distributed Only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated