FDA-Device2026-10-22Class IIPACKAGING DEFECT

Medline C-Section Pack recalled for difficult removal and adhesive residue

OTHERNationwide distributionMedical devices

What this means

Medline's C-Section Pack medical convenience kits (product number DYNJ48455A) may be difficult to remove from patients and can leave adhesive residue on skin. The issue affects approximately 222 units distributed in the US and several other countries.

  • Check if you have Medline C-Section Pack lot numbers 26FBV563 or 26ABH473.
  • If you use this product, contact Medline Industries for guidance on affected units.
  • Do not use affected kits for new patients; switch to an alternative product.
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The agency's original wording
Hazard

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
Affected count
222 units
Manufactured in
3 Lakes Dr, Northfield, Illinois, United States
Products
MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0273-2027

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