Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2380-2014)

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:

OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK SPONGES (1) MEASURE DISP. PAPER TAPE 24" (1) IMP .REINFORCED GOWN XLge. SMS STERILE (1) TABLE COVER Reinf. L/Free (1) SYRINGE 1cc W/NDL. 25G X 5/8 SLIP TIP L/Free (2) PAD OBSTETRICAL XLGE ST. (1) UNDERBUTTOCK DRAPE W/POUCH (1) SYRINGE 10cc W/0 NDL. L/Free (1) SYRINGE 20cc W/ONDL. L/Lock L/Free (1) FEEDING TUBE 8 Fr. 15" LONG (1) BABY BLANKET IMP. POLY ABS. (1) NEEDLE HYPODERMIC 23GA X 1" (6) ABSORBENT TOWELS L/Free (1) WRAPPER 24" X 24" 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-2380-2014

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: 1 lot; 30 units (multiple units per lot)

Code Information:

Product code 900-1238, 1 lots: 109071538

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