Epimed RX-2 COUDE Epidural Needle Recalled for Potential Sterility Seal Defect
Epimed International is recalling 500 units of RX-2 COUDE Epidural Needles due to a potential incomplete seal that may impact sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential sterility defect, which poses a risk of harm (infection) even though no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Epimed International is recalling 500 units of RX-2 COUDE Epidural Needles, 16g x 3.5in (8.9cm)TW. The recall is due to a potential for a partially incomplete seal of the product, which may impact sterility.
The affected product is identified by Lot No. 12168200 and Ref No. 107-1416. The needles were distributed domestically to Arkansas, California, Iowa, Indiana, Kentucky, Louisiana, Michigan, New York, Ohio, Oregon, Tennessee, Texas, and Washington. They were also distributed to Canada, the Czech Republic, Germany, and Turkey.
Healthcare providers and facilities should stop using the affected needles and contact Epimed International for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- 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
- Manufacturer
- Epimed International
- Hazard
- Affected units
- 500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot No. 12168200
- Ref No. 107-1416.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Epimed International under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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