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Recall Observatory FDA recall evidence

Drug product

Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211.

D-227-2013

March 04, 2013

Class II

Product summary

Firm
CareFusion 213, LLC
Event
Event 64583
Status
Terminated
Classification
Class II
Quantity
929,000 kits
Official record key
drug-enforcement:D-227-2013

Official wording

Reason: Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

Code information: All lots with expiry between 12/11 to 10/15.

Distribution pattern: Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    misbranded