FDA-Device2026-10-21Class IIPROCESSING DEFECT

Medline surgical convenience kits recalled for cannula components that may leak or break

OTHERNationwide distributionMedical devices

What this means

Medline distributed surgical convenience kits (Neuro-Spine Basin Pack and AV Shunt Pack) containing cannula components that do not meet required dimensional standards. These components may leak or break during medical use.

  • Check if your facility received the affected Medline kits (SKU DYNJ80055A or DYNJ24528M) with the lot numbers listed in the recall notice.
  • Do not use affected kits in patient procedures.
  • Contact Medline or the FDA if you have questions about whether your kits are affected.
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The agency's original wording
Hazard

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
1900 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0177-2027

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