| | Class 2 Device Recall Cardinal Health Presource Kits |  |
| Date Initiated by Firm | November 08, 2024 |
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| Date Posted | February 10, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1129-2025 |
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| Recall Event ID |
95947 |
| Product Classification |
Cardiovascular procedure kit - Product Code OEZ
|
| Product | Cardinal Health Presource Kits:
1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B;
2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D
3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103
4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T
5) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10U
6) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10X
7) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10Y
8) SLH AAA PACK, Catalog Number:SCV13AASLA
9) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAF10
10) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH4
11) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH5
12) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH6
13) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH7
14) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH8
15) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH9
16) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHP
17) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHQ
18) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHR
19) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHS
20) NEURO EMBOLISM PACK, Catalog Number:SNE11AN102
21) NEURO EMBOLISM PACK, Catalog Number:SNE11AN10E |
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| Code Information |
1) PVV20110B, UDI-DI:10197106291412 (each) 50197106291410 (case), Lot Number: 6788690 ;
2) PVV20110B, UDI-DI:10197106291412 (each) 50197106291410 (case), Lot Number: 6806122 ;
3) PVV20110B, UDI-DI:10197106291412 (each) 50197106291410 (case), Lot Number: 7160517 ;
4) PVV20110D, UDI-DI:10197106546505 (each) 50197106546503 (case), Lot Number: 7287574 ;
5) PVV2CA103, UDI-DI:10888439714081 (each) 50888439714089 (case), Lot Number: J46C12 ;
6) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J46C11 ;
7) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J43W16 ;
8) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J6022K ;
9) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J7708R ;
10) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J79Z50 ;
11) PVV2CA10U, UDI-DI:10888439693607 (each) 50888439693605 (case), Lot Number: J8241D ;
12) PVV2CA10U, UDI-DI:10888439693607 (each) 50888439693605 (case), Lot Number: J84K11 ;
13) PVV2CA10X, UDI-DI:10888439967265 (each) 50888439967263 (case), Lot Number: J8998R ;
14) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5140389 ;
15) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5664115 ;
16) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5858468 ;
17) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5858469 ;
18) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 6116189 ;
19) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 6251075 ;
20) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7055826 ;
21) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7287469 ;
22) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7331456 ;
23) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7332825 ;
24) SCV30VAF10, UDI-DI:10197106231142 (each) 50197106231140 (case), Lot Number: 6702001 ;
25) SCV30VAFH4, UDI-DI:10195594091989 (each) 50195594091987 (case), Lot Number: J8045P ;
26) SCV30VAFH5, UDI-DI:10195594154073 (each) 50195594154071 (case), Lot Number: 5138326 ;
27) SCV30VAFH6, UDI-DI:10195594243616 (each) 50195594243614 (case), Lot Number: J9699Y ;
28) SCV30VAFH7, UDI-DI:10195594324940 (each) 50195594324948 (case), Lot Number: 5405620 ;
29) SCV30VAFH8, UDI-DI:10195594381400 (each) 50195594381408 (case), Lot Number: 5138335 ;
30) SCV30VAFH9, UDI-DI:10195594616182 (each) 50195594616180 (case), Lot Number: D212939 ;
31) SCV30VAFH9, UDI-DI:10195594616182 (each) 50195594616180 (case), Lot Number: 5775803 ;
32) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J3986T ;
33) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J4219R ;
34) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J4877C ;
35) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J6278H ;
36) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J6786K ;
37) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J76N07 ;
38) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J86N63 ;
39) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J86N65 ;
40) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J70X09 ;
41) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J9424P ;
42) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7332861 ;
43) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6701998 ;
44) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6748352 ;
45) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6748352 ;
46) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6470289 ;
47) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6775068 ;
48) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6775065 ;
49) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7005466 ;
50) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7280092 ;
51) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7280093 ;
52) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7005463 ;
53) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7332855 ;
54) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6022069 ;
55) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6133658 ;
56) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6232003 ;
57) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6345513 ;
58) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6416679 ;
59) SNE11AN102, UDI-DI:10197106232293 (each) 50197106232291 (case), Lot Number: 6568688 ;
60) SNE11AN10E, UDI-DI:10197106067062 (each) 50197106067060 (case), Lot Number: 6560950 ;
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Recalling Firm/
Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
|
| For Additional Information Contact | Cardinal Health Quality Systems
800-292-9332 |
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Manufacturer Reason
for Recall | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
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FDA Determined
Cause 2 | Material/Component Contamination |
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| Action | An URGENT: MEDICAL DEVICE CORRECTION OVER LABEL notification letter dated 11/8/24 was sent to customers.
If you locate affected product within your facility, please complete the following:
1. QUARANTINE affected kits & ALERT your clinicians of this action
2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all CODMAN Patties & Strips included with the Presource product.
3. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648.
Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332. |
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| Quantity in Commerce | 973,785 total units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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