medical_device

Basin/bowl liner or equipment cover (drape). Product codes: 17700, 16700A, 3109N, 3109NT, 3108N, 33099, 9386001, 3309N, TP1909A, TP1909B. All lot numbers. These products (a type of surgical drape) are manufactured by Microtek Medical, but may be distributed by other companies. These devices will have been supplied in procedure packs. See page 5 of the manufacturer’s FSN for full product descriptions. All devices manufactured since August 2009 are affected by this recall.

Surgical equipment/ Anaesthesia - surgical equipment

Burr Hole Latex Free Probe Cover

PC3688 and 3688UK | see FSN

MD: Intraoperative ultrasound imaging system transducer cover

Ultrasonics - ultrasonic diagnostic equipment

Ultrasound probe cover: Burr hole probe cover with gel. These ultrasound probe covers are disposable, single-use drapes. They are used as a cover for ultrasound probe scan heads and power cords, used for various surgical procedures, to provide a barrier over the equipment. Product reference (SKU number): 3688UK, PC3688, PC3688EU. Affected batch numbers are listed in the Field Safety Notice (FSN). Note that product ref (SKU number) 3688 is listed in the FSN but it is not for sale in the UK.

md

Model Catalog: PC3688 (Lot serial: > 10 numbers contact mfg); Model Catalog: 3688 (Lot serial: D112301); Model Catalog: 3688 (Lot serial: DA91671); Model Catalog: 3688 (Lot serial: DA91061); Model Catalog: 3688 (Lot serial: DA90621); Model Catalog: 3688 (Lot serial: D91671); Model Catalog: 3688 (Lot serial: D83261); Model Catalog: 3688 (Lot serial: D120821); Model Catalog: 3688 (Lot serial: D110831); Model Catalog: 3688 (Lot serial: D111441)

Bur Hole Latex Free Probe Cover with Gel

Microtek Medical: da Vinci Surgical System drapes

Model Number: Affected product for Tear-Away Labels: 420015-03, 420022-02, 420256-01, 420258-01, 420279-03, 420291-03, 420290-03 Affected product for Cloudy / Waxy Appearance: 400015-03, 400016-04, 400027-04, 420015-03, 420017-03, 420022-02, 420026-01, 420256-01, 420258-01, 420273-02, 420279-03, 420281-02, 420290-03, 420291-03 Batch Number: All lot numbers greater than 066 as seen in the following format D15066xx or DA15066xx.

Medical devices for single use

400015-03, 400016-04, 400027-04, 420015-03, 420017-03, 420022-02, 420026-01, 420256-01, 420258-01, 420273-02, 420279-03, 420281-02, 420290-03, 420291-03 | See list

MD: Instrument/equipment drape, single-use, sterile

Lot Numbers: D100891, D101191, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521, D122361, D81701, D83031, D90231, D90911, D91171, D91821, D92081, D92301, D92601, D92801, D93411, DA82321, DA82451, and DA90891

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.

MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.

Lot Numbers: 126429V, 126602V, 126611V, 126612V, 126613V, 126614V, 127176V, 127182V, 127331V, 127382V, 137533V, 137826V, 137967V, 137666V, 137787V, and 137817V

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.

MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

Lot Numbers: D100131, D100341, D101521, D101861, D101871, D101881, D101891, D101901, D101931, D101941, D101951, D102491, D102531, D102651, D102731, D110691, D110831, D110841, D111021, D111111, D111221, D111381, D111451, D111651, D111801, D111961, D112091, D112231, D112371, D112511, D112661, D112791, D112911, D113061, D113211, D113341, D113481, D120111, D120261, D120401, D120551, D120661, D120811, D120811A, D120941, D121091, D121311, D121371, D121511, D121661, D121681, D122141, D122431, D122561, D122991, D130581, D81701, D81711, D82661, D83041, D83501, D90691, D90701, D91611, D92011, D92021, D92121, D92431, D92601, D92991, D93061, DA100051, DA100061, DA100341, DA100951, DA100971, DA101511, DA101521, DA102011, DA81931, DA82451, DA83011, DA83031, DA83241, DA91131,DA91141, DA91601, and DA92881

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.

MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

Lot Numbers: D101931, D101981, D102471, D110561, D111801, D112301, D112511, D112991, D113421, D120191, D120651, D121521, D122221, D123401, D130171, D130311, D130431, D82061, D82321, D82871, D83371, DA101891, DA81561, DA82061, and DA85161

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.

MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

Lot Numbers: D102471, D102661, D102701, D110831, D111101, D111151, D111231, D111441, D112301, D112851, D112991, D113551, D120821, D121181, D121951, D122421, D130171, D130381, D82321, D82871, D83261, D90261, D91671, DA102491, DA90491, DA90621, DA91061, and DA91671

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.

MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

15302

General Hospital and Personal Use Devices

2

No

US Distribution to the states of : CA, FL, MI, NJ, TX, UT and VA..

Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.

Lot numbers D152291, D160961, D161161, D161311, D161371, and D161721.

Radiology Devices

2

No

US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.

ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. || To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).

Lot numbers D151871, D151961, D161861, D162001, and D162911

Radiology Devices

2

No

US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.

ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. || To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).

Lot Numbers: C9272 and C10078

General Hospital and Personal Use Devices

2

No

US (nationwide) Distribution.

FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX || The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.