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Terminated

Non-continuous ventilators under the following brand names: a) Sync S/T Lab, w/o modem US/CAN model number 1010771; b) Sync S/T Lab, w/o modem US/CAN-RENT model number R1010771; c) Synchrony S w/o modem US/CAN model number 1002816; d) Tranquility Ultrafine Qty 1 model number 1039671; and e) Tubing Coupler model number 300065. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall Z-1088-2008 · Posted 2008-04-24

Recalling FirmRespironics, Inc.
Recall StatusTerminated
Product CodeMNS
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.

K071509BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEMRespironics Inc., Sleep & Home Respiratory Group · 2007-08-08K020777BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEXRespironics, Inc. · 2002-03-20

Official Source

View FDA Recall →

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

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