Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2350-2014)

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:

NEURO PACK- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) BAG SUTURE FLORAL (1) MAYO STAND COVER REINFORCED LIF (2) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 14" X 48" L/F (1) SHEET SPLIT WITH ADHESIVE 1 08" X 77" STD SMS LIF (1) TOP DRAPE WITH ADHESIVE 1 08" X 50" 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-2350-2014

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: 37 lots; 858 units (multiple units per lot)

Code Information:

Product code 900-752, 37 lots: 109020288 109040862 109051218 109081882 109112704 110010111 110020448 110041015 110061538 110071775 110081984 110122945 111010161 111020378 111030658 111040919 111051388 111061566 111071943 111082111 111092403 111092464 111102780 111123294 112020512 112030745 112093950 112124705 112125113 113036768 113078345 113088889 113099454 113099588 113109872 120141354 131110277

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