FDA-Device2026-10-14Class IIMISBRANDING
HALYARD Laparoscopy Comprehensive Pack II recalled for undeclared latex in urethral catheter
What this means
HALYARD Laparoscopy Comprehensive Pack II (REF: 49332) was labeled as "latex free" but contained a latex urethral catheter. This mislabeling poses a risk to patients with latex allergies who may use the kit. The recall affects 396 kits with specific lot numbers distributed nationwide.
- Check if you have HALYARD Laparoscopy Comprehensive Pack II REF: 49332 with lot numbers GL25271CXA, GL25296CXA, or GL26076CXA
- If you have an affected kit, do not use it and contact your distributor or HALYARD for instructions
- Review patient records if this product was already used in procedures, especially for patients with known latex allergies
The agency's original wording
Hazard
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of MS.
Affected count
396 kits
Manufactured in
1805 Honggao Road, Nanhu District, Jia Xing, N/A, China
Products
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0077-2027Want us to check the next one for you?
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