Device Recall Medline

Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015

General and Plastic Surgery Devices

2

No

Nationwide distribution: New York only.

Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D || This custom pack includes components necessary for a specific procedure.

Affected Biological Indicator Lot No.: S-444

General Hospital and Personal Use Devices

2

No

Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.

Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 || EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.

Affected Biological Indicator Lot No.:130401

General Hospital and Personal Use Devices

2

No

Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.

Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR || SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome

Reorder Number: HCS02; All units produced since July 2006.

Anesthesiology Devices

2

No

Nationwide Distribution

Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.

Reorder Number: HCS021; All units produced since July 2006.

Anesthesiology Devices

2

No

Nationwide Distribution

Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS021; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.