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Class 2 Device Recall noncontinuous ventilators |
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Date Initiated by Firm |
October 15, 2007 |
Date Posted |
April 24, 2008 |
Recall Status1 |
Terminated 3 on September 01, 2009 |
Recall Number |
Z-1057-2008 |
Recall Event ID |
45545 |
510(K)Number |
K040595 K982454 K982454 K040595
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Product Classification |
ventilation accessories - Product Code GWQ
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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. |
Code Information |
Lot Numbers 071010, 071011, and 071012. |
Recalling Firm/ Manufacturer |
Respironics, Inc. 1001 Murry Ridge Ln Murrysville PA 15668-8550
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For Additional Information Contact |
Katherine dePadua 724-387-7770
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Manufacturer Reason for Recall |
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = GWQ and Original Applicant = RESPIRONICS, INC.
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