FDAFDA · Food and drugs·Recall number Z-0087-2018
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
Published November 15, 2017 · Recall initiated: July 24, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for partially incomplete seal of product, impacting sterility.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Epimed International
- Distributor
- Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
- Lot
- Lot No. 12168200; Ref No. 107-1416.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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