Home / Recalls / Respire Medical / Z-1947-2018

Z-1947-2018 Class II Terminated

Recalled by Respire Medical — Brooklyn, NY

Recall Details

Product Type
Devices
Report Date
June 6, 2018
Initiation Date
September 1, 2017
Termination Date
December 9, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

Respire Pink Series EF+ Oral Sleep Apnea Device.

Reason for Recall

Potential for device breakage during use

Distribution Pattern

US nationwide distribution.

Code Information

Serial Number: 50837

Other recalls by Respire Medical

  • Z-1948-2018 Class II — Respire Pink+ Hard/Soft Oral Sleep Apnea Device (September 1, 2017)
  • Z-1951-2018 Class II — Respire Pink H/S Oral Sleep Apnea Device (September 1, 2017)
  • Z-1950-2018 Class II — Respire Pink H/S Oral Sleep Apnea Device (September 1, 2017)
  • Z-1949-2018 Class II — Respire Pink+ Hard Oral Sleep Apnea Device (September 1, 2017)