Z-1057-2008

Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number...

Name: Z-1057-2008 Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number...
Creator: Respironics, Inc.
Published: 2007-10-15
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2007-10-15 / Terminated / root cause: manufacturing process

FDA source

Respironics, Inc. began a recall of Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model... on 2007-10-15. The reason FDA records is "Foreign material: Glass fragments may present in the plastic bag material used to ship components". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1057-2008
Status: Terminated
Initiated: 2007-10-15
Posted: 2008-04-24
Terminated: 2009-09-01
Recalling firm: Respironics, Inc.
Product: Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Single model number 312710; d) Alice 5, Domestic model number 1017226; e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS; f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS; g) BIPAP Auto M, W/SmartCard, US model number DS700S; h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716; i) BIPAP Harmony, Intl model number 1012823; j) BIPAP Plus M, US model number DS600; k) BIPAP Plus M, W/Humid US model number DS600H; l) BIPAP S/T Core Pkg NA model number 1014248; m) BIPAP S/T North America model number 1012885; n) BIPAP Vision Filter Pack model number 582101; o) Duet LX/BIPAP Pro/Synch Pollen QTY 1 model number 1039611; p) FLXTB, 5 inch STD, 22 mm, CE model number 1006042; q) FLXTB, 6 in Trach 15 mm taper, CE model number 1004968; r) GP UL-Fine Filter 2 pack model number 1006190; s) Incoming Filter 7000, 7001 CPAP model number 7070; and t) Infant ECG Electrodes model number 1016361. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Product code: GWQ Full-Montage Standard Electroencephalograph
Reason for recall: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
Quantity in commerce: 20950 units
Distribution: The products were shipped nationwide to medical facilities.
Product codes and lots: Lot Numbers 071010, 071011, and 071012.

Product code GWQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)