Continuous Epidural Anesthesia Kit W/Poly Catheter

510(k) K884552

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK884552	Date14 Mar 1989Cleared	StatusActive

8 recalls · 1 ongoing · FDA

- Ongoing Z-2364-2026 FDA Class I initiated 21 Apr 2026
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
2 recalls, same reason
- Terminated Z-1252-2020 FDA Class II initiated 20 Dec 2019
- Terminated Z-1244-2020 FDA Class II initiated 20 Dec 2019
Product lidstock contains the incorrect expiration date for the product
3 recalls, same reason
- Terminated Z-2013-2018 FDA Class II initiated 11 Apr 2018
- Terminated Z-1957-2018 FDA Class II initiated 11 Apr 2018
- Terminated Z-1961-2018 FDA Class II initiated 11 Apr 2018
Product sterility may be compromised due to unsealed packaging.
- Terminated Z-1080-2015 FDA Class II initiated 5 Jan 2015
The product labeling does not specify the 5 year shelf life of the product.
- Terminated Z-1012-2011 FDA Unclassified (pre-2012) initiated 11 Nov 2010
Sterility may be compromised.

1 jurisdiction

United States — FDA 510(k) Active

510(k)