Public recall detail

Presource Kits Containing the SafeAir Smoke Evacuation Pencil components

2024-11-07

medium
Recall Safety notice
Quick summary

Quick summary: Presource Kits Containing the SafeAir Smoke Evacuation Pencil components. Date: 2024-11-07.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Presource Kits Containing the SafeAir Smoke Evacuation Pencil components. Date: 2024-11-07.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandCardinal Health
ProductPresource Kits Containing the SafeAir Smoke Evacuation Pencil components
IssueMedical devices - Performance
Recall classType I
IdentificationRA-76457

Affected products

ProductCardiac Implant Pack
Lot865549 890536 968250 8042 114212
ModelPC30VPGTI
Serial number865549 890536 968250 8042 114212
DescriptionCardiac Implant Pack
ProductGeneral Plastic Surgery Packs
Lot1102 863873 936838 974272
ModelPW30APGTD PW30APG11 PW30APGT9
Serial number1102 863873 936838 974272
DescriptionGeneral Plastic Surgery Packs
ProductFistula Kits
Lot864803 916085 944990 874821 922975 939357
ModelPV30AVGTF
Serial number864803 916085 944990 874821 922975 939357
DescriptionFistula Kits
ProductKidney Transplant Kits
Lot896250 919613 24238 830254
ModelPD30KTGTF
Serial number896250 919613 24238 830254
DescriptionKidney Transplant Kits
ProductMajor Vascular Kits
Lot947521 899537 35093 54489 930043
ModelPV30MJG14 PV30MJG15 PV30MJG13 PV30MJG16 PV30MJG17
Serial number947521 899537 35093 54489 930043
DescriptionMajor Vascular Kits
ProductLaparoscopy Packs
Lot873244 35000 835467 925593 961983 981243 10633 890826
ModelPG30LGG10 PG30LGGTE
Serial number873244 35000 835467 925593 961983 981243 10633 890826
DescriptionLaparoscopy Packs
ProductExtremity Pack
Lot40441 903998 944617
ModelSOP30XTSV5 SOP30XTSV4 SOP30XTSV8
Serial number40441 903998 944617
DescriptionExtremity Pack
ProductThoracic Pack
Lot68638 955359 23843 915901 939275 862948 1078 10644
ModelPH30MJG11 PH30MJGTE
Serial number68638 955359 23843 915901 939275 862948 1078 10644
DescriptionThoracic Pack
ProductMinor Packs
Lot871334 885360 946213 978439 8031 967661 85281 43501 20705
ModelPW30IPGTC PW30IPGT4
Serial number871334 885360 946213 978439 8031 967661 85281 43501 20705
DescriptionMinor Packs
ProductCarotid Endarterectomy Kits
Lot20652 887015
ModelPV30CAGTF
Serial number20652 887015
DescriptionCarotid Endarterectomy Kits
ProductUrology Packs
Lot971491 838875 24267 890506
ModelPU30OTGTE
Serial number971491 838875 24267 890506
DescriptionUrology Packs
ProductCaesarian (C) Section Packs
Lot8364 57883 830690 904929 942180 38633
ModelSMA30CSSVK
Serial number8364 57883 830690 904929 942180 38633
DescriptionCaesarian (C) Section Packs
ProductCoronary Artery Bypass Grafting (Cabg) Packs
Lot252400
ModelPC30CBTGB
Serial number252400
DescriptionCoronary Artery Bypass Grafting (Cabg) Packs
ProductEndovascular Aneurysm Repair (Evar) Packs
Lot946236 1058 33046 916200 922660 55766 939345
ModelPC30OYGTI PC30OYG16 PC30OYG15
Serial number946236 1058 33046 916200 922660 55766 939345
DescriptionEndovascular Aneurysm Repair (Evar) Packs
ProductBypass (Pontage) Packs
Lot948955 109900 976827 1971 903212 838028 227292 877040 280645 941801 887016
ModelPC30CGGTL PC30CGGTJ PC30CGG24 PC30CGGTK PC30CGG22 PC30CGG23
Serial number948955 109900 976827 1971 903212 838028 227292 877040 280645 941801 887016
DescriptionBypass (Pontage) Packs
ProductHeart Pack
Lot48096
ModelSCV30OHKGM
Serial number48096
DescriptionHeart Pack
ProductMinor Breast Kits
Lot24210 3405 895576 973622
ModelPW30BJGTD
Serial number24210 3405 895576 973622
DescriptionMinor Breast Kits
ProductLiver Transplant Kits
Lot1060 919120 196788 829985 903192
ModelPD30LVGTG PD30LVGTH
Serial number1060 919120 196788 829985 903192
DescriptionLiver Transplant Kits
ProductLung Transplant Kit
Lot973032 78151 1059 18263 871319
ModelPD30LTGTH
Serial number973032 78151 1059 18263 871319
DescriptionLung Transplant Kit
ProductGeneral Gynaecology (Gyne) Packs
Lot14301 931451 882486 947119 989968 895226
ModelPB30MJGTF
Serial number14301 931451 882486 947119 989968 895226
DescriptionGeneral Gynaecology (Gyne) Packs
ProductBreast Packs
Lot977246 51862 983259 23130 931417 902810 868651 947055
ModelPG30MJPHD
Serial number977246 51862 983259 23130 931417 902810 868651 947055
DescriptionBreast Packs
ProductMastectomy Pack
Lot940510 960164 57842 898486
ModelSBA30MAUH7 SBA30MAUHD
Serial number940510 960164 57842 898486
DescriptionMastectomy Pack
ProductVascular Limb Kits
Lot12204 830255 945007 964694 863373 990445 903243 79474
ModelPV30LVGTD PV30LVGT9
Serial number12204 830255 945007 964694 863373 990445 903243 79474
DescriptionVascular Limb Kits
ProductChest Opening Packs
Lot45723 829984 18038 999975 903151 838029
ModelPC30OTGTF
Serial number45723 829984 18038 999975 903151 838029
DescriptionChest Opening Packs
ProductGynaecology Surgery (Chirurgie Gynecologique) Packs
Lot887145 15455 916634 944568 973574
ModelSMA30GLSVD
Serial number887145 15455 916634 944568 973574
DescriptionGynaecology Surgery (Chirurgie Gynecologique) Packs
ProductHip Prosthesis Packs (Ens. Strl Prosthese De Hanche)
Lot5918 39298
ModelSOP30HAVIA
Serial number5918 39298
DescriptionHip Prosthesis Packs (Ens. Strl Prosthese De Hanche)
ProductMajor Neck Kits
Lot883711 1064 57270 3533 979555 969968 911314
ModelPE30HMG10 PE30HMGTE PE30HMGT8
Serial number883711 1064 57270 3533 979555 969968 911314
DescriptionMajor Neck Kits
ProductTrachea/Thyroid Packs
Lot957247 832650 942215 80207 972299 996045 827592
ModelSEN30THPHE SEN30THPH8
Serial number957247 832650 942215 80207 972299 996045 827592
DescriptionTrachea/Thyroid Packs
ProductNeck Kits
Lot36102 868296 933644 955383 977941 2936 911315
ModelPE30HNGTF
Serial number36102 868296 933644 955383 977941 2936 911315
DescriptionNeck Kits
ProductRobotic Surgery (Chirurgie Robotique) Packs
Lot830837 7992 55409
ModelPG30MCGTF
Serial number830837 7992 55409
DescriptionRobotic Surgery (Chirurgie Robotique) Packs
ProductVideo Assisted Thoracoscopic Surgery (Vats) Packs
Lot161995 937646 250585 883766 837942 977939
ModelPH30TSGTF PH30TSGTE
Serial number161995 937646 250585 883766 837942 977939
DescriptionVideo Assisted Thoracoscopic Surgery (Vats) Packs
ProductHepatopancreaticobiliary (Hpb) Kits
Lot1073 32921 977699 924799
ModelPG30OTG12 PG30OTG13 PG30OTGTJ
Serial number1073 32921 977699 924799
DescriptionHepatopancreaticobiliary (Hpb) Kits
ProductOpen General Surgery (Gen Surg) Kits
Lot863345 935506 8125 903214 973098 882568 835448 955307
ModelPG30LPGTE
Serial number863345 935506 8125 903214 973098 882568 835448 955307
DescriptionOpen General Surgery (Gen Surg) Kits

Issue

Cardinal Health was informed of a medical device recall from Stryker Instruments concerning the SafeAir Smoke Evacuation Pencils. The recall is being issued due to the potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Recall start date: October 31, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use Health products - Medical devices - General and plastic surgery Health products - Medical devices - Cardiovascular Health products - Medical devices - Anaesthesiology
CompaniesCardinal Health 3651 Birchwood Drive, Waukegan, Illinois, United States, 60085
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-76457
Background{}
CompaniesCardinal Health 3651 Birchwood Drive, Waukegan, Illinois, United States, 60085
AudiencesHealthcare
Source updated2024-11-13

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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