Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2415-2014)

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:

HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WIT APE LIF (4) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) DRAPE SHEET 41" X 58" SMS LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (10) GAUZE 4" X 4" 4PLY (2) UTILITY BOWL 16oz LIF (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (1) BLADE SURGICAL#10 STAILESS STEEL (1) SURGICAL DURAPREP SOLUTION 26m! LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (10)GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGE PRE WASH 18" X 18" XRD LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 33" (2) SHEET DRAPE 70" X 100" LIF (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS L/F 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-2415-2014

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: 3 lots; 36 units (multiple lots per unit)

Code Information:

Product code 900-1835, 3 lots: 113109763 131210771 140412619

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