Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2436-2014)

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:

FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET 42" X 57" SMS LIF (1) SAFETY IV INTROCAN 18 X 1X ST. LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF (2) VESSEL LOOP SURGICAL MAXI BLUE (1) SUTURE AID BOOT STD YELLOW ST. LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) EMESIS BASIN 101N 700cc LIF (2) LIGHT SHIELD (1) NEEDLE HYPODERMIC 18G X 1 L/F (1) CATHETER IV SAFETY 20G X 1X LIF (1) DRAPE T LAPAROT 102" X 78" X 121" SMS STD LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER I LOCK LIF (1) SUTURE BAG FLORAL LIF (2) UTILITY BOWL 16oz. L/F (1) CAUTERY TIP POLISHER LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (4) DRAPE UTILITY WITH TAPE LIF (1) MAYO TRAY SMALL (1) SCALPEL SAFETY WEIGHTED #15 (1) SCALPEL SAFETY WEIGHTED #11 (2) TUBE SUCTION CONNECT X" x 12' LIF (2) NEEDLE & BLADE COUNTER, 1Oc MAG/CLEAR LIF (1) TIME OUT BEACON NON WOVEN ST. LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER L/F 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-2436-2014

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: 11 lots/432 units, (multiple units per lot)

Code Information:

Product code 900-2164, 11 lots 112041224 112083167 113036762 113047217 113067914 113078468 113088852 131210646 140312118 140412645 140513125

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