Customed, Inc: Medical Device Recall in 2015 - (Recall #: Z-2638-2015)

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:

MINOR PACK 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-2638-2015

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: 1452

Code Information:

Code:9002511 Lots: 140412903 exp. 5/31/16 140915507 exp. 10/31/15 141216305 exp. 12/31/15 150116550 exp. 1/31/16 150116549 exp. 1/31/16 150116552 exp. 1/31/16 150116551 exp. 1/31/16 150317840 exp. 4/30/16 150317839 exp. 4/30/16 150317841 exp. 4/30/16 150317841 exp. 4/30/16 150317842 exp. 4/30/16 150317843 exp. 4/30/16 150317844 exp. 4/30/16 150418372 exp. 4/30/16 150418373 exp. 4/30/16 150418374 exp. 4/30/16 150418375 exp. 5/31/16

Distribution Pattern:

Distributed Only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated