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Recall Observatory FDA recall evidence

Device product

Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Z-0018-2019

August 01, 2018

Class II

Product summary

Firm
COVIDIEN LLC
Event
Event 80924
Status
Terminated
Classification
Class II
Quantity
2,730,821 units in total
Official record key
device-enforcement:Z-0018-2019

Official wording

Reason: Potential for product sterility breach due to a compromised or pinched seal defect

Code information: Lot Numbers: 18D180762,18D180862,18E029062,18E029162,18E029262, 18E029362,18E070662,18E070462,18E070562,18E130962, 18E131062,18E166462,18E166562,18E131162,18E222562, 18E222462,18F034562,18F034462,18F034362,18F072562, 18F072462,18F122462,18F122362

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility breach due to a compromised or pinched seal defect