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Recall Observatory FDA recall evidence

Device product

IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE SUCTION CONNECT \14'' X 12' LIF ( I) BAG GLASSINE LIF (2) LITE GLOVE LIF (2) TABLE COVER 50" X 90" REINFORCED LIF ( I) MAYO STAND COVER REINFORCED LIF (5) TOWEL ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 70" X I 00" LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F ( I) MAYO TRAY LARGE LIF ( I) DRAPE TOP WITH ADHESIVE LIF ( I) SKIN STAPLE 35 WIDE LIF ( I) BULB SYRINGE 60cc LIF ( I) UTILITY BOWL 16oz L/F (2) UTILITY BOWL 32oz L/F ( I) INCISION DRAPE 23" X I 7" L/F (I) SKIN MARKER WITH RULER LIF ( I) U-DRAPE 54" X 72" W/TAPE SPLIT 6" X 2 1" LIF (2) ABDOMINAL PAD 8" X 7.5" L/F ( I) YANKAUER SUCTION TUBE W/0 VENT L/F (I) DURAPREP SURGICAL SOLUTION 26ML LIF ( I) SURGICAL BLADE # 10 STAINLESS STEEL (I) SPLIT SHEET W/ADH 108" X 77"" STD SMS LIF ( I) IMP. STOCKINETTE LIF (I) *Pr. SURGEON NEUTRALON GLOVE #7 ~ LATEX ( I) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX (I) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX (I) SURGEON GOWN REINF. T/WRAP X-LARGE LIF (2) IMP. GOWN REINFORCED X-LARGE SMS LIF (I) PENCIL CAUTERY ROCKER SWITCH LIF (I) SURGICAL BLADE #20 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Z-2394-2014

May 20, 2014

Class I

Product summary

Firm
Customed, Inc
Event
Event 68536
Status
Terminated
Classification
Class I
Quantity
12 lots; 399 units (multiple units per lot)
Official record key
device-enforcement:Z-2394-2014

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: Product code 900-1476, 12 lots: 112030618 112072885 112104097 112114378 112114555 112124949 113015689 113047329 113078255 113088832 113089191 121104357

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

    reason.labeling_packaging · v1.0.0

    packaging integrity may be compromised
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility