Device Recall

Model CVT808015, Lot numbers: 9895996, 9904675, 9910270, 9911926, 9912084, 9912200, 9922490, 9922584, 9922597, 9922601, 9922604, 9922606, 9922617, 9922620, 9922624, 9922635, 9923420, 9924840, 9928078, 9932274, 9933341, 9933774, 9933839, 9933934, 9934029, 9934440, 9934633, 9934686, 9936420, 9937544, 9937660, 9942679, 9943032, 9945436, 9948145, 9949409, 9950000, 9950703.   Model CVT808025, Lot numbers: 9904237, 9906429, 9910270, 9912003, 9912117, 9912261, 9922644, 9922658, 9922661, 9922663, 9922739, 9922862, 9922868, 9923391, 9923401, 9923405, 9923428, 9923437, 9923454, 9924796, 9924802, 9924826, 9924847, 9924853, 9928334, 9928629, 9929004, 9929248, 9929344, 9933577, 9933797, 9933903, 9934553, 9934772, 9935134, 9935174, 9935241, 9935245, 9935471, 9935523, 9935757, 9935889, 9936140, 9936631, 9936680, 9936702, 9936735, 9937706, 9938500, 9938960, 9939918, 9939985, 9940234, 9940687, 9940916, 9948001, 9948544, 9949603, 9950150, 9950722, 9951391, 9952404, 9952785, 9952844, 9959913.   Model CVT812015, Lot Numbers: 9904401, 9904676, 9910934, 9912387, 9922742, 9922793, 9922886, 9922892, 9922902, 9922904, 9922917, 9923224, 9923226, 9923237, 9923268, 9923275, 9923398, 9923446, 9923453, 9924832, 9932594, 9933474, 9933813, 9933924, 9934192, 9934730, 9936820, 9937095, 9937806, 9942701, 9943235, 9945140.   Model CVT812025, Lot Numbers: 9910342, 9911492, 9911683, 9911812, 9912503, 9922498, 9922750, 9922753, 9922873, 9922911, 9923246, 9923403, 9923404, 9923409, 9923426, 9923442, 9923450, 9923457, 9924848, 9925351, 9933666, 9934311, 9934575, 9934700, 9935143, 9935199, 9935494, 9935636, 9935900, 9936109, 9936173, 9936570, 9936597, 9936848, 9937896, 9937968, 9938060, 9938219, 9938831, 9938896, 9941711, 9945304, 9947559, 9948088, 9949321, 9949934, 9950324, 9951247, 9951521, 9952927, 9957277, 9957530, 9959854, 9959944, 9960241, 9960324, 9960635, 9960807, 9961583, 9961682, 9962504, 9963558, 9964120, 9964347, 9964448, 9965066, 9965335, 9966329, 9966429, 9966999, 9967656, 9967694, 9968180, 9969396, 9972428, 9972429, 9972819, 9972867, 9972966.

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. || Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

SK514470022YA, SK514470023YA, SK514470024YA, SK514470020YA, SK514470021YA, SK514100003YA, SK514470019YA, SK514470001YA, SK514470017YA, SK514470018YA, SK514450021YA, SK514450022YA, SK514450019YA, SK514470004YA, SK514470005YA, SK514390001YA, SK514150002YA, SK514150004YA, SK514150005YA, SK514300002YA

Cardiovascular Devices

2

No

Distributed in the US and Europe.

VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.

LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205

Orthopedic Devices

2

Yes

US Distribution to states of: AZ, CA, NY, TN and TX including PR.

Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. || Spinal Surgical Device.

Mfg Lot or Serial # System ID 0000013C2A0001 203694IGS730 0000011C2A0005 610954OR1 0000014A2A0009 718283D740 0000014A2A0007 SO4208228 0000014A2A0016 SO4242294 0000014A2A0004 206VMDISCOVERY1 Not available 330375HOR 0000014A2A0006 190020RX26 Not available 190059RX30 Not available SO4165355 Not available 82416120043 Not available 82416040061 00000011C2A003 A4185526 0000012C2A0002 M4160476 0000014A2A0008 S41600101 00000612802BU9 M54866AG1 Not available M40480222 Not available HC4348XR11 0000014A2A0001 YV2000 Not available XR649425BU6 Not available SO4239583 Not available AE1477RX04 0000013A2A0003 00169VAS01 0000013A2A0002 10692VAS01

Radiology Devices

2

No

Worldwide Distribution-Distributed in the states of CO, CT, MS, NJ, NY, OH, and WA, and the countries of BELGIUM, CANADA, CHINA, FRANCE, GERMANY, JAPAN, MEXICO, PERU, UNITED ARAB EMIRATES, and UNITED KINGDOM.

GE Healthcare, Discovery IGS 730 & Discovery IGS 740. || Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. || Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.

Mfg Lot or Serial # System ID 00000437461CN7 519646REVO1 00000437837CN8 M2322254 00000438342CN8 828210096 00000437028CN4 REV001 00000438864CN1 900010CT06 00000439199CN1 260010CT19 00000439068CN8 AE1477CT01 00000437787CN5 786596WKRIVO 00000438503CN5 206598REV1 00000438951CN6 309655REVCT 00000439029CN0 801662REV1 00000439160CN3 212241REVCT 00000439367CN4 415476MCT3

Radiology Devices

2

No

US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.

GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.