ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

FDA recall notice · announced July 23, 2014 · Carefusion 213

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

Reason for recall

Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.

Notes

Distribution: Nationwide in U.S.
Lot/code information: Lot #: 71132, Expiry: 02/2017
Quantity: 23,000 Applicators
Status: Terminated
Products in this recall event:
- ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13. (D-1442-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.