FDA Updates

ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical ChemoLock Port REF: CL2100

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical ChemoLock w/Mini Bag Spike REF: C-17

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical ChemosafeLock Connecter REF: KL-FNU3

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause: Under Investigation by firm

Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;

Reason: The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.

Root cause: Under Investigation by firm

Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 138919-01 138920-01 138921-01 138922-01 138923-01 138924-01 138926-01 138927-01 138928-01 138929-01 138930-01 138931-01 138932-01 138933-01 138934-01 138936-01 138937-01 138938-01 138939-01 138940-01 138941-01 138942-01 138943-01 138944-01 138945-01 138946-01 138947-01 138948-01 138949-01 138950-01 138951-01 138952-01 138953-01 138954-01 138955-01 138956-01 138957-01 138958-01 138959-01 138960-01 138961-01 138962-01 138963-01 138964-01 138965-01 138966-01 138967-01 138968-01 138969-01 138970-01 138971-01 138972-01 138973-01 138974-01 138975-01 138976-01 138977-01 138978-01 138989-01 138990-01 139000-01 139001-01 139002-01 139011-01 139013-01 139016-01 139018-01 139019-01 139020-01 139021-01 139022-01 139023-01 139028-01 139062-01 139063-01 139073-01 139082-01 139084-01 139085-01 139086-01 139091-01 139122-01 139125-01 139126-01 139127-01 139128-01 139131-01 139141-01 139142-01 139156-01 139163-01 139170-01 139171-01 139172-01 139174-01 139175-01 155081-01 155082-01 155083-01 155084-01 155085-01 155086-01 155087-01 155088-01 155089-01 155090-01 155091-01 155092-01 155093-01 155094-01 155095-01 155096-01 155097-01 155098-01 155099-01 155100-01 155101-01 155102-01 155103-01 155104-01 155105-01 155106-01 155107-01 155108-01 155109-01 155110-01 155111-01 155112-01 155113-01 155114-01 155115-01 155116-01 155117-01 155118-01 155119-01 155120-01 155121-01 155122-01 155123-01 155124-01 155125-01 155126-01 155127-01 155128-01 155129-01 155130-01 155131-01 155132-01 155133-01 155134-01 155135-01 155136-01 155137-01 155138-01 155139-01 155140-01 155141-01 155142-01 155143-01 155144-01 155145-01 155146-01 155147-01 155148-01 155149-01 155150-01 155151-01 155152-01 155153-01 155154-01 155155-01 155156-01 155157-01 155159-01 155160-01 155161-01 155163-01 155165-01 155166-01 155167-01 155168-01 155169-01 155171-01 155288-01 155293-01 155294-01 155299-01 155302-01 155303-01 155304-01 155305-01 155310-01 155311-01 169-03 169-04 169-05 169-06 169-07 169-08 169-09 169-10 169-100 169-101 169-102 169-103 169-104 169-105 169-106 169-107 169-108 169-109 169-11 169-110 169-111 169-112 169-113 169-114 169-115 169-12 169-120 169-124 169-125 169-127 169-128 169-129 169-13 169-131 169-132 169-137 169-138 169-139 169-14 169-140 169-141 169-142 169-143 169-144 169-145 169-15 169-150 169-151 169-152 169-155 169-156 169-159 169-16 169-160 169-161 169-162 169-163 169-164 169-18 169-19 169-20 169-21 169-22 169-23 169-24 169-25 169-26 169-27 169-28 169-29 169-30 169-31 169-32 169-33 169-34 169-35 169-36 169-37 169-38 169-39 169-40 169-41 169-42 169-43 169-44 169-45 169-46 169-47 169-48 169-49 169-50 169-51 169-52 169-53 169-54 169-55 169-56 169-57 169-58 169-59 169-60 169-61 169-62 169-63 169-64 169-65 169-66 169-67 169-68 169-69 169-70 169-71 169-72 169-73 169-74 169-75 169-76 169-77 169-78 169-79 169-80 169-81 169-82 169-83 169-84 169-85 169-86 169-87 169-88 169-89 169-90 169-91 169-92 169-93 169-94 169-95 169-96 169-97 169-98 169-99

Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-01 139064-01 139065-01 139066-01 139067-01 139068-01 139069-01 139070-01 139071-01 139072-01 139164-01 139165-01 300

Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Root cause: Under Investigation by firm