Recall Z-0086-2017— Epimed International, Inc.
Class II · Terminated
Class II FDA medical device recall by Epimed International, Inc., initiated 2016-04-22, terminated 2018-06-14. It names one FDA 510(k) clearance: K072005. Product: 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia. Reason: There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention..
- Recalling firm
- Epimed International, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-22
- Terminated
- 2018-06-14
- Firm location
- Johnstown, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
Reason for recall
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
Data sourced from openFDA. This site is unofficial and independent of the FDA.