Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2426-2014)

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:

SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) SHEET DRAPE 70" X 100" SMS LIF (1) CUP SPECIMEN WITH CAP 4oz (1) TUBE SUCTION CONNECT. Y." X 12' LIF (1) SKIN MARKER WITH RULER (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (1) BAG SUTURE FLORAL LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 21G X 1% LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE SPINAL ANESTH. 18G X 3% LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) DRAPE BEACH CHAIR SHOULDER ARTHROSC. (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP (2) GAUZE SPONGE 4" X 4" 16PL Y XRD 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-2426-2014

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: 16 lots; 327 units (multiple units per lot)

Code Information:

Product code 900-1985, 16 lots: 112030698 112041408 112083418 112093632 112114384 112114490 112125051 113025843 113026052 113026108 113036788 113057730 113078294 113088775 113099406 140111191

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