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Terminated

Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x 50 ft model number 1008841; d) RP-Vision Filter Cover model number 1003444; e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and f) RP-Wrap, Cord model number F35195. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall Z-1085-2008 · Posted 2008-04-24

Recalling FirmRespironics, Inc.
Recall StatusTerminated
Product CodeCBK
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.

K982454BIPAP VISION VENTILATORY SUPPORTRespironics, Inc. · 1998-11-03K842876PORTABLE LIFECARE VENTILATOR PLV-102Lifecare Services, Inc. · 1984-08-29

Official Source

View FDA Recall →

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

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