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.
This recall has been terminated (originally issued April 24, 2008).
- Company
- Respironics, Inc.
- Recall Initiated
- October 15, 2007
- Posted
- April 24, 2008
- Terminated
- September 1, 2009
- Recall Number
- Z-1085-2008
- Quantity
- 20950 units
- Firm Location
- Murrysville, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Distribution
The products were shipped nationwide to medical facilities.
Lot / Code Info
Lot Numbers 071010, 071011, and 071012.
Root Cause
Environmental control
Action Taken
The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
More recalls by Respironics, Inc.
Respironics Trilogy 100, 200, and 202 Ventilators
The Respironics Trilogy systems provides continuo...
Jul 23, 2012
Trilogy 100, 200 and 202 Ventilators
The device is intended to be used in home, institution/hospita...
Jan 11, 2012
Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Mon...
Jun 24, 2010