Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2304-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

Product Classification:

Class I

Date Initiated: May 20, 2014

Date Posted: September 10, 2014

Recall Number: Z-2304-2014

Event ID: 68536

Reason for Recall:

Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Status: Terminated

Product Quantity: 30 lots, 6977 units (multiple units per lot)

Code Information:

Product code 900-028, 30 lots: 111071871 112041386 112041433 112051660 112051712 112062301 112062560 112093834 112124408 112124903 112125312 113015686 113026162 113036772 113047331 113057830 113068022 113068136 113078564 113089015 113089177 113099559 131110062 131110395 131110575 140111089 140111447 140211739 140312327 140513052

Distribution Pattern:

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated