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Terminated

Non-continuous ventilator accessories under the following brand names: a) RP-ComfortGel Gel Cushion M model number 1009050; b) RP-ComfortGel Gel Cushion P model number 1009048; c) RP-ComfortGel Gel Cushion S model number 1009049; d) RP-ComfortGel Silicone Flap L model number 1009109; e) RP-ComfortGel Silicone Flap M model number 1009054; and f) RP-ComfortGel Silicone Flap S model number 1009053. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall Z-1079-2008 · 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.

K954207GEL MASKRespironics, Inc. · 1996-01-31

Official Source

View FDA Recall →

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

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