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
Reported: November 9, 2016 Initiated: April 22, 2016 #Z-0086-2017
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.
Details
- Recalling Firm
- Epimed International, Inc.
- Units Affected
- 576 units
- Distribution
- US Distribution to the states of : AL, AK, FL, IN, TN & TX
- Location
- Johnstown, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Epimed International, Inc.. Units affected: 576 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 9, 2016. Severity: Moderate. Recall number: Z-0086-2017.
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