Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 8886...
FDA Recall #Z-1178-2023 — Class II — December 2, 2022
Product Description
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT 88861932-51 SURGILON* 2-0 BLK 75CM GS10 88861971-71 SURGILON* 1 BLK 75CM GS21 88861985-71 SURGILON* 1 BLK 75CM SC1X36 SBS-1884G SURGILON* 4-0 WHI 45CM P12X12 SBS-1928G SURGILON* 5-0 BLK 45CM P13X12
Reason for Recall
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Recalling Firm
Covidien, LP — North Haven, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
87708 units
Distribution
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
Code Information
GTIN: 20884521073996, 20884521076652, 10884521072183, 20884521072180, 10884521071223, 20884521071220, 10884521071797, 20884521071794, 20884521071763, 20884521071787, 20884521071749, 10884521073838, 20884521073835, 20884521076669, 10884521076662, 10884521071766, 20884521071725, 10884521071513, 20884521071510. Model Number Lot # 8886188351 D1K1677FY 8886191571 D2C3242Y 8886191931 D2B2243Y 8886191941 D1M2553Y D1M2561Y D2B0169Y 8886191951 D1M0915Y D2A0560Y D2B1245Y D2B1537Y D2B2751Y D2C0267Y D2C0907Y D2C1101Y D2D2347Y D2D2437Y D2D2506Y D2D2510Y D2E0905Y 8886191961 D1M1423Y D2A0861Y D2A0865Y D2A1709Y D2B1349Y D2B1350Y D2B2727Y 8886191971 D1M0640Y D1M1494Y D2C0962Y 8886193251 D1G1867Y 8886197171 D2B0290Y D2B0445Y D2B0476Y 8886198571 D1E0626Y SBS1884G D1E1212FY SBS1928G D2B0707FY D2C3247FY
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated