Recall Z-1785-2026— Cook Incorporated
Class II · Ongoing
Class II FDA medical device recall by Cook Incorporated, initiated 2026-03-05. It names 2 FDA 510(k) clearances: K160200, K010016. Product: Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.. Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life..
- Recalling firm
- Cook Incorporated
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-05
- Firm location
- Bloomington, IN, United States
510(k) clearances named in this recall
2 on FDA's record- K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
- K010016 — MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
K-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
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
Reason for recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.