Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2441-2014)

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:

SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" (2) UTILITY BOWL 16oz (1) TRAY ORGANIZER FULL DEEP (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (1) YANKAUER SUCTION TUBE WITHOUT VENT (5) LAP SPONGE PREWASH 18" X 18" XRD (1) BLADE SURG. #15 CARBON STEEL (2) NEEDLE & BLADE COUNTER 1Oc MAG/CLEAR (1) CAUTERY TIP POLISHER (1) BLADE SURG. #10 CARBON STEEL (2) LITE GLOVE (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) CAUTERY PENCIL ROCKER SWITCH (1) TIME OUT BEACON NON WOVEN ST Product Usage: 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-2441-2014

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: 31 lots/5900 units, (multiple units per lot)

Code Information:

Product code 900-2224, 31 lots 111030809 111040974 111051186 111051439 111061657 111123221 112010132 112020464 112030725 112041296 112083423 112093932 112114389 112114662 113015447 113025955 113026235 113036792 113057462 113067868 113078471 113088791 113099288 113109791 131110239 140111204 140211659 140312122 140312381 140412899 140513478

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