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Moderate riskFDA DeviceClass II

Cardinal Health spine procedure kits recalled over endotoxin levels

Cardinal Health is recalling certain Presource spine procedure kits because they contain MEDICOM Ritmed Neurological Sponges, which were recalled over unexpected variability in endotoxin levels. The affected kits are catalog number SOP30SPBCC, lots 12206 and 13289, and about 456 kits were distributed in the US and Canada. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls

What to do

  1. Check kit packaging for catalog number SOP30SPBCC and lot 12206 or 13289.
  2. Hold any affected kits and follow your facility's recall procedures.
  3. Contact Cardinal Health about return or replacement, since the notice does not specify a remedy.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 8 products — see all of them.

Details

Units affected
456 kits
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Classification
Class II
Recall number
Z-2943-2026

In the FDA's words

Description
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. 1) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 3) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; Distribution: US Nationwide. Canada. Affected quantity: 456 kits
Hazard
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

8 products in this recall

Cardinal Health Presource kits recalled for endotoxin variability

Cardinal Health is recalling 8 Presource procedure kit product groups, sold under the Cardinal Health Presource Kits name, that contain MEDICOM Ritmed Neurological Sponges. The sponges had unexpected variability in endotoxin levels. The kits were distributed across the US and to Canada, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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