NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Reported: August 25, 2021 Initiated: December 28, 2017 #Z-2313-2021
Product Description
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Reason for Recall
Potential for stylet to protrude from the distal end of the catheter
Details
- Recalling Firm
- Epimed International
- Units Affected
- 140 units
- Distribution
- Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
- Location
- Farmers Branch, TX
Frequently Asked Questions
What product was recalled? ▼
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile. Recalled by Epimed International. Units affected: 140 units.
Why was this product recalled? ▼
Potential for stylet to protrude from the distal end of the catheter
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 25, 2021. Severity: Moderate. Recall number: Z-2313-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11