Customed, Inc: Medical Device Recall in 2015 - (Recall #: Z-2606-2015)

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 LAP. PACK 5/CS REV. 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-2606-2015

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: 945

Code Information:

Code:9001735 Lots: 140814973 exp. 11/30/15 141015733 exp. 10/31/15 141216417 exp. 12/31/15 141216417 exp. 12/31/15 150217361 exp. 2/28/16 150217362 exp. 2/28/16 150217363 exp. 2/28/16 150217364 exp. 2/28/16 150418267 exp. 4/30/16 150418266 exp. 4/30/16 150518660 exp. 5/16/16 150518661 exp. 5/31/16

Distribution Pattern:

Distributed Only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated