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GRI Medical & Electronic Technology Co., Ltd.: HALYARD Laparoscopy Comprehensive Pack II REF: 49332

Medical DevicesSource: FDA (device) · Date: 2026-10-14

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
GRI Medical & Electronic Technology Co., Ltd.
Product
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Reason / hazard
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of MS.
Recall initiated
2026-08-26
Code info
UDI-DI: 10680651493320 (unit level), 30680651493324 (case level) Lot Numbers: GL25271CXA-Expiry Date: 2029/3/30; GL25296CXA-Expiry Date: 2029/3/30; GL26076CXA-Expiry Date: 2029/5/31
Product quantity
396 kits
Voluntary mandated
Voluntary: Firm initiated
City
Jia Xing
State
N/A
Country
China
Event id
99813
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