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Recall Observatory FDA recall evidence

Device product

Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13

Z-1172-2023

December 02, 2022

Class II

Product summary

Firm
Covidien, LP
Event
Event 91324
Status
Ongoing
Classification
Class II
Quantity
9606
Official record key
device-enforcement:Z-1172-2023

Official wording

Reason: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information: GTIN: 10884521070981 20884521070988 20884521070797 10884521070790 20884521070797 20884521070698 10884521070691 20884521070834 10884521070806 20884521070803 20884521070698 10884521070691 20884521070797 Lot # (1) D2B0701Y, D2E3000Y (2) D1M2315FY, D1M2326FY,D2F1873FY (3) D2B2781FY (4) D2B1309FY (5) D1J0777FY

Distribution pattern: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Sterile Barrier Breach