Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2525-2014)

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:

Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4" X 4" 16PLY LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (2) CUP DENTURE 8oz TEAL WITH LID LIF (6) TOWEL CLOTH HUCK BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET% DRAPE REINFORCED 60" X 77" LIF (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F L/F (2) PR. GLOVE SURG CUSTOMGUARD CHLOROPRENE #6.5 P/F L/F (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS L/F (1) DRAPE BOTTOM ABS REINF. 71" X 62" STD SMS WITH TAPE L/F (2) DRAPE SIDE 42" X 76" WITH TAPE LIF (1) PVP IODOPHOR BOTTLE 4oz PAINT (1) SUCTION TUBING 8' X 3/8" ID NON CONDUCTIVE LIF (1) STRIP STERI CLOSURE Y2" X 4" 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-2525-2014

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/ 35 units, multiple units per lot

Code Information:

900-3115, 2 lots: 131211011 140111439

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