Customed, Inc: Medical Device Recall in 2015 - (Recall #: Z-2564-2015)

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:

PERY GYN PACK CUSTOMED 10/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-2564-2015

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: 460 packs

Code Information:

Code:9001091 Lots: 141015789 exp. 5/31/19 141115972 exp. 12/31/15 150116985 exp. 1/31/16 150217441 exp. 2/28/16 150217442 exp. 2/28/16 150418281 exp. 4/30/16 150518223 exp. 5/31/16 150519018 exp. 5/31/16

Distribution Pattern:

Distributed Only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated