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Terminated

Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS; c) REMStar Pro M w/Smartcard US model number DS400S; d) REMStar Pro/Plus Silencer Cap model number 1005962; e) REMStar Pro/Plus/Auto/Lite Pollen model number 1005964; f) REMStar Pro/Plus/Auto/Lite Pollen SNGL model number 1001389; g) REMStar Pro/Plus/Auto/Lite Ultrafine model number 1005945; and h) REMStar Pro/Plus/Auto/Lite Ultrafine Qty 1 model number 1039607. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall Z-1069-2008 · Posted 2008-04-24

Recalling FirmRespironics, Inc.
Recall StatusTerminated
Product CodeBZD
Date Initiated2007-10-15
Date Terminated2009-09-01
Product Quantity20950 units

Reason for Recall

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

Firm Action

The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.

Root Cause

Environmental control

Distribution Pattern

The products were shipped nationwide to medical facilities.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052110M-SERIES PRO CPAP SYTEMRespironics, Inc. · 2005-10-20K021861REMSTAR PRO WITH C-FLEX CPAP SYSTEMRespironics, Inc. · 2002-06-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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