Customed, Inc: Medical Device Recall in 2015 - (Recall #: Z-2713-2015)

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:

CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

Product Classification:

Class II

Date Initiated: July 10, 2015

Date Posted: September 9, 2015

Recall Number: Z-2713-2015

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: 1038

Code Information:

Code: 900944 Lots: 141015772 exp. 10/31/15 141015772 exp. 10/31/15 150116981 exp. 1/31/16 150116827 exp. 2/28/16 150116828 exp. 2/28/16 150116829 exp. 2/28/16 150317866 exp. 4/30/16 150317867 exp. 4/30/16 150317868 exp. 4/30/16 150317869 exp. 4/30/16 150418428 exp. 4/30/16 150418426 exp. 4/30/16 150418427 exp. 4/30/16 150418585 exp. 5/31/16 150418586 exp. 5/31/16 150619298 exp. 6/30/16 150619299 exp. 6/30/16

Distribution Pattern:

Distributed Only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated