2007 Product Recalls
1,625 recalls issued in 2007.
Showing 1621–1625 of 1,625 recalls
Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.
Press Release was issued 11/29/05. Hospital/physician letters sent via registered mail on 11/29/05 for delivery on 12/01/05. Unimplanted devices are being retrieved. The Physician letter describes the issue, root cause, the probability of reoccurrence and provides recommendations. A list of affected serial numbers that the physician is following or has implanted is attached to the letter. The letter also provides medtronic's website in which regular updates on the ongoing actual performance are listed in their Product Performance Report. Medtronic is providing a replacement device should the Physician and patient elect to replace the affected implanted device.
5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers; Made in USA for: Medline Industries; BEMIS label has Manufactured by Bemis Mtg. Co., Sheboygan Falls, WI.
The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container.
Letters were mailed to consignees August 23, 2006 describing the product with lots and model numbers. Customers were asked to have product destroyed rather than returned to Bemis. Enclosed with the letter was a Recall Acknowledgement/Destroy in field form that they were instructed to fax to BEMIS. A second letter was sent out to the non-responders on September 13, 2005.
Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-1000 is a prescription medical device suitable for use in institutional, home and transport settings.
Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.
Urgent Medical Device Recall letter dated 11/09/05 is being sent via certified mail to affected customers. The letter informs customers of the issue. A Pulmonetic Systems representative will contact the customer within 72 hours to schedule a printed circuit board replacement. Customers are advised that in the interim all ventilator-dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction occurs, alternate ventilation can be provided.
Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR W/INTRO KIT; MTI451845 4.5FR MINI T/A; MTI551845 5.5FR MINI TA; MTI651845 6.5FR MINI T/A; P460OTW SNGL LUM PICC W/MTI; P4552K DBL LUM PICC INTRO KIT; P5552K DBL LUM PICC INTRO KIT; P4552KOTW DBL LUM OTW PICC INTRO KIT LF; LOCKING T/A INTRODUCERS 11FR; INTRADYN TEAR-AWAY INTRODUCER 4F; INTRADYN TEAR-AWAY INTRODUCER 5F; INTRADYN TEAR-AWAY INTRODUCER 6F; INTRADYN TEAR-AWAY INTRODUCER 7F; INT
Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.
Recall letters shere sent out to the firm''s customers on 5/27/2005 via US Mail, Return Receipt Requested.
NOS Kits for Snowmobiles and ATVs Recalled for Overheating Hazard
An incorrect burst disc, a component of the NOS bottle valve, may have been installed in the recalled NOS Kits. If the bottle is overfilled and overheated, it could forcefully burst, posing an impact injury hazard to consumers.
Consumers should stop using the recalled NOS system for snowmobiles and ATVs immediately and contact NOS to have the burst disc replaced. Registered owners have been notified about this recall by mail.