Device product
Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (20) GAUZE SPONGES 4 X 4 12PLY L/F (6) TOWELS CLOTH HUCK C BLUE L/F (2) TIP ABSORB. APPLIC STICK SPONGE LIF (1) STRIP STERI CLOSURE LIF (1) CUP DENTURE 8oz. TEAL WITH LID (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) SYRINGE 10ML DARK GREEN (1) SYRINGE 10ML YELLOW L/F (1) LITE GLOVE LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2488-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2 lots/ 112 units, multiple units per lot
- Official record key
device-enforcement:Z-2488-2014
Official wording
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.
Code information: 900-2654, 2 lots: 112062214 112093599
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.
Derived failure modes
-
Labeling or packaging
packaging integrity may be compromised
-
Sterility assurance
loss of sterility