PlainRecalls
FDA Devices Moderate Class II Terminated

TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only

Reported: November 15, 2017 Initiated: July 24, 2017 #Z-0089-2018

Product Description

TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only

Reason for Recall

Potential for partially incomplete seal of product, impacting sterility.

Details

Recalling Firm
Epimed International
Units Affected
263 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?
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only. Recalled by Epimed International. Units affected: 263 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-0089-2018.