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
Reported: November 15, 2017 Initiated: July 24, 2017 #Z-0087-2018
Product Description
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
Reason for Recall
Potential for partially incomplete seal of product, impacting sterility.
Details
- Recalling Firm
- Epimed International
- Units Affected
- 500 units
- Distribution
- Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
- Location
- Farmers Branch, TX
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Epimed International. Units affected: 500 units.
Why was this product recalled? ▼
Potential for partially incomplete seal of product, impacting sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2017. Severity: Moderate. Recall number: Z-0087-2018.
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