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Recall Observatory FDA recall evidence

Device product

DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10

Z-0927-2023

December 12, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91331
Status
Terminated
Classification
Class II
Quantity
157 packs
Official record key
device-enforcement:Z-0927-2023

Official wording

Reason: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.

Code information: a) REF 89-9004.09, GTIN 00749756903936, Lot Numbers: 57391129 exp 5/1/2023, 57755421 exp 5/1/2023, 57900931 exp 5/1/2023 b) REF 89-9004.10, GTIN 00749756903931, Lot Numbers: 57913767 exp 5/1/2023

Distribution pattern: US Nationwide distribution in the states of IL, MO.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing error
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile barrier breach