Recall Z-2402-2014— Customed, Inc

Class I FDA medical device recall by Customed, Inc, initiated 2014-05-20, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: UNIVERSAL PACK - (1) TRAY ORGANIZER FULL DEEP (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 20G X 1 ~ UF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF (1) SHEET% 57" X 63" REINFORCED SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY LIF (1 0) GAUZE SPONGES 4" X 4" 12PL Y LIF (4) CLOTH HUCK TOWELS BLUE LIF (1) TABLE COVER REINFORCED 50" X 90" UF (1) SCALPEL WITH HANDLE #11 (1) DENTURE CUP WITH LID (1) TRAY 2 COMPARTMENT (2) ABSORBENT TIP APPLICATOR (1) IMPERVIOUS STOCKINETIE 14" X 48" LIF (1) TAPE TRANSPORE 1" X 36" (1) DIISP NEEDLE 30 X ~ (1) PROBE DRAPE 6" X 96 WITH GEL (1) ARTERIAL NEEDLE 18 X 2 % (1) CATHETER INTRODUCER 7FR (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Reason: 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..

Recalling firm

Customed, Inc

Classification

Class I

Status

Terminated

Initiated

2014-05-20

Terminated

2017-08-14

Firm location

Fajardo, PR, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.