Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2418-2014)

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:

LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE ENDOSCOPY 1 00" X 123W' X 77" WITH TROUGHS (1) MAYO STAND COVER REINFORCED LIF (4) TOWEL ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (5) GAUZE SPONGE 2" X 2" 4PL Y (1) CORD LAPAROSCOPY FOOD SWICHING MONOPOLAR (1) SCALPEL WEIGHTED SAFETY #11 (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LITE GLOVE UF (1) SUTURE BAG FLORAL UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (1) UTILITY BOWL 32oz. (2) SHEET DRAPE 42" X 57" SMS (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (5) TAPE TEGADERM 2 3/8 X 2 o/. UF (5) LAP SPONGE PREWASH 18" X 18" XRD L/F (2) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE (1) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE TOWEL/WRAP 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-2418-2014

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: 18 lots; 882 units (multiple units per lot)

Code Information:

Product code 900-1913, 18 lots: 112030657 112041913 112051896 112062467 112114653 112125043 113026231 113036784 113057438 113078284 113088771 113099399 113109766 131110211 131210772 140311185 140412620 140412878

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