Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-2395-2014)

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:

E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED L/F (1) TUBE SUCTION CONNECT %" X 12' L/F (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL HAND SWITCHING (2) ABSORBENT TOWELS 15" X 20" L/F (1) DRAPE SHEET 41 " X 58" SMS L/F (1) EAR/ULCER SYRINGE 2oz LIF (2) MEDICINE CUP 2oz (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) *Pr. SURGICAL GLOVES #7% POWDER (1) *Pr. SURGICAL GLOVES #7 POWDER (9) LABEL FOR SKIN MARKER 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-2395-2014

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: 39 lots; 1771 units (multiple units per lot)

Code Information:

Product code 900-1482, 39 lots: 110102428 110112608 110123088 111010049 111020265 111030581 111040888 111051317 111061497 111071865 111082190 111092354 111102683 111113009 111123347 112010050 112020371 112030620 112041188 112051766 112062419 112083396 112093898 112124950 112125282 113025940 113036669 113047197 113067888 113068256 113078256 113109732 131210747 140111083 140211641 140312070 140312453 140513090 140613609

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