Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2363-2014)

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:

ARHTROSCOPY PACK- (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE (1) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (1) BAG SUTURE FLORAL (1) STOCKINETTE IMPERVIOUS 14" X 48" (4) STRIPS TAPE 24" X 4" (1) SHEET EXTREMITY ABS. 125" X 85" (1) TIME OUT BEACON NON WOVEN ST. 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-2363-2014

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; 540 units (multiple units per lot)

Code Information:

Product code 900-982, 11 lots: 112093957 112114688 112125123 113025981 113067944 113078479 113088900 113109884 131110285 140111261 140412707

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