Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2307-2014)

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 Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes, table cover, drape sheet, suture bag, duraprep surgical solution, cloth huck towels, utility bowls, suction tube, scalpel, Mayo Tray, Mayo Cover, & lite gloves. 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-2307-2014

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: 32 lots; 8954 units (multiple units per lot)

Code Information:

Product code 900-149, 32 lots: 111113165 111123349 112010052 112010280 112030621 112041077 112051768 112062421 112083062 112093900 112104147 112114637 112114952 113015429 113025941 113026204 113036749 113047333 113057861 113078258 113078600 113089192 113109733 131110083 131110399 131110578 131210961 140111409 140211872 140312328 140412830 140513345

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