Home / Recalls / Smiths Medical ASD Inc. / Z-0146-2025

Z-0146-2025 Class II Ongoing

Recalled by Smiths Medical ASD Inc. — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
October 30, 2024
Initiation Date
July 18, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27,971 units

Product Description

smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

Reason for Recall

Uncertainty in the seal integrity of the sterile packaging.

Distribution Pattern

Worldwide distribution.

Code Information

UDI/DI 35019315022405, Lot Numbers: 4122013, 4130776, 4130777

Other recalls by Smiths Medical ASD Inc.

  • Z-1667-2025 Class I — CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21 (April 10, 2025)
  • Z-1662-2025 Class I — CADD Solis HSPCA Pump (April 10, 2025)
  • Z-1681-2025 Class I — CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE (April 10, 2025)
  • Z-1682-2025 Class I — CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, (April 10, 2025)
  • Z-1668-2025 Class I — CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21- (April 10, 2025)
  • Z-1404-2025 Class II — CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100 (February 14, 2025)
  • Z-1405-2025 Class II — CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 (February 14, 2025)
  • Z-1283-2025 Class I — smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8 (February 13, 2025)
  • Z-1289-2025 Class I — Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111 (February 13, 2025)
  • Z-1285-2025 Class I — smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow (February 13, 2025)