Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2488-2014)

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:

Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (20) GAUZE SPONGES 4 X 4 12PLY L/F (6) TOWELS CLOTH HUCK C BLUE L/F (2) TIP ABSORB. APPLIC STICK SPONGE LIF (1) STRIP STERI CLOSURE LIF (1) CUP DENTURE 8oz. TEAL WITH LID (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) SYRINGE 10ML DARK GREEN (1) SYRINGE 10ML YELLOW L/F (1) LITE GLOVE LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF 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-2488-2014

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: 2 lots/ 112 units, multiple units per lot

Code Information:

900-2654, 2 lots: 112062214 112093599

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