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Recall Observatory FDA recall evidence

Device product

Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478

Z-2088-2023

May 30, 2023

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 92445
Status
Ongoing
Classification
Class II
Quantity
328 packs
Official record key
device-enforcement:Z-2088-2023

Official wording

Reason: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Code information: a) REF 89-10640, GTIN 50749756367740 (cs), 00749756367745 (unit), Lot Numbers: 58737945; b) REF 89-10901, GTIN 50749756380244 (cs), 00749756380249 (unit), Lot Numbers: 58820749; c) REF 89-1924, GTIN 50749756216864 (cs), 00749756216869 (unit), Lot Numbers: 58746227; d) REF 89-7133, GTIN 50749756736744 (cs), 00749756736749 (unit), Lot Numbers: 58789323; e) REF 89-9134, GTIN 50749756911332 (cs), 00749756911337 (unit), Lot Numbers: 58701336; f) REF 89-9478, GTIN 50749756926909 (cs), 00749756926904 (unit), Lot Numbers: 58738454

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    package seal could be open, or compromised
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    package seal could be open, or compromised which affects the sterility