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Recall Observatory FDA recall evidence

Device product

LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWEL 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL #15 CARBON STEEL (2) UTILITY BOWL 16oz (1) UTILITY BOWL 32oz (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) EMESIS BASIN 10in 700cc (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF (2) TUBE SUCTION CONNECT 114" X 12' LIF (1) TABLE COVER REINFORCED 44" X 78" UF (1) DRAPE LAP. PERINEAL 102" X 97" WITH POUCH (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Z-2335-2014

May 20, 2014

Class I

Product summary

Firm
Customed, Inc
Event
Event 68536
Status
Terminated
Classification
Class I
Quantity
34 lots; 1136 units (multiple units per lot)
Official record key
device-enforcement:Z-2335-2014

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 900-605, 34 lots: 110092266 110102447 110112666 110123109 111010142 111020291 111030694 111040908 111061557 111071939 111082104 111092395 111102768 111113129 111123270 112010189 112020490 112030886 112051997 112062497 112072807 112083435 112093728 112124593 112125104 113078336 113088877 113099445 113109859 131110267 131210832 140111091 140312177 140412696

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