| | Class 1 Device Recall Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Electrophysiology Catheter |  |
| Date Initiated by Firm | July 14, 2025 |
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| Date Posted | August 28, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2460-2025 |
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| Recall Event ID |
97357 |
| 510(K)Number | K241156 |
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| Product Classification |
Catheter, recording, electrode, reprocessed - Product Code NLH
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| Product | Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models
401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH, 401310RH, 401311RH, 401312RH, 401317RH, 401353RH, 401357RH, 401381RH, 401392RH, 401399RH, 401400RH, 401425RH, 401430RH, 401433RH, 401434RH, 401435RH, 401436RH, 401438RH, 401441RH, 401442RH, 401445RH, 401443RH, 401444RH, 401448RH, 401449RH, 401450RH, 401451RH, 401453RH, 401466RH, 401468RH, 401474RH, 401475RH, 401859RH, 401860RH, 401863RH, 401864RH, 401865RH, 401876RH, 401877RH, 401878RH, 401890RH, 401891RH, 401892RH, 401893RH, 401966RH, 401967RH, 401979RH, 401994RH, 401996RH, 402004RH, 402008RH, 402009RH, 402010RH, 402011RH, 402012RH |
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| Code Information |
1) 401211RH, UDI-DI: 10197344043736(each), 10197344043736(case), Lot Number: EP250106;
2) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP241118;
3) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP250106;
4) 401223RH, UDI-DI: 10197344043705(each), 10197344043705(case), Lot Number: EP250106;
5) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP241118;
6) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP250106;
7) 401227RH, UDI-DI: 10197344043682(each), 10197344043682(case), Lot Number: EP250106;
8) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP241118;
9) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP250106;
10) 401261RH, UDI-DI: 10197344043651(each), 10197344043651(case), Lot Number: EP250106;
11) 401305RH, UDI-DI: 10197344043637(each), 10197344043637(case), Lot Number: EP250106;
12) 401309RH, UDI-DI: 10197344043613(each), 10197344043613(case), Lot Number: EP250106;
13) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP241118;
14) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP250106;
15) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP241118;
16) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP250106;
17) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP241118;
18) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP250106;
19) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case), Lot Number: EP241118;
20) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case), Lot Number: EP250106;
21) 401433RH, UDI-DI: 10197344043484(each), 10197344043484(case), Lot Number: EP241118;
22) 401434RH, UDI-DI: 10197344043477(each), 10197344043477(case), Lot Number: EP241118;
23) 401435RH, UDI-DI: 10197344043460(each), 10197344043460(case), Lot Number: EP241118;
24) 401436RH, UDI-DI: 10197344043453(each), 10197344043453(case), Lot Number: EP250106;
25) 401441RH, UDI-DI: 10197344043439(each), 10197344043439(case), Lot Number: EP241118;
26) 401441RH, UDI-DI: 10197344043439(each), 10197344043439(case), Lot Number: EP250106;
27) 401442RH, UDI-DI: 10197344044245(each), 10197344044245(case), Lot Number: EP241118;
28) 401442RH, UDI-DI: 10197344044245(each), 10197344044245(case), Lot Number: EP250106;
29) 401443RH, UDI-DI: 10197344044252(each), 10197344044252(case), Lot Number: EP241118;
30) 401443RH, UDI-DI: 10197344044252(each), 10197344044252(case), Lot Number: EP250106;
31) 401444RH, UDI-DI: 10197344044269(each), 10197344044269(case), Lot Number: EP241118;
32) 401444RH, UDI-DI: 10197344044269(each), 10197344044269(case), Lot Number: EP250106;
33) 401448RH, UDI-DI: 10197344044283(each), 10197344044283(case), Lot Number: EP250106;
34) 401449RH, UDI-DI: 10197344044290(each), 10197344044290(case), Lot Number: EP241118;
35) 401449RH, UDI-DI: 10197344044290(each), 10197344044290(case), Lot Number: EP250106;
36) 401450RH, UDI-DI: 10197344044306(each), 10197344044306(case), Lot Number: EP241118;
37) 401450RH, UDI-DI: 10197344044306(each), 10197344044306(case), Lot Number: EP250106;
38) 401451RH, UDI-DI: 10197344044313(each), 10197344044313(case), Lot Number: EP241118;
39) 401451RH, UDI-DI: 10197344044313(each), 10197344044313(case), Lot Number: EP250106;
40) 401453RH, UDI-DI: 10197344044320(each), 10197344044320(case), Lot Number: EP250106;
41) 401474RH, UDI-DI: 10197344044351(each), 10197344044351(case), Lot Number: EP241118;
42) 401474RH, UDI-DI: 10197344044351(each), 10197344044351(case), Lot Number: EP250106;
43) 401860RH, UDI-DI: 10197344044382(each), 10197344044382(case), Lot Number: EP241118;
44) 401860RH, UDI-DI: 10197344044382(each), 10197344044382(case), Lot Number: EP250106;
45) 401863RH, UDI-DI: 10197344044399(each), 10197344044399(case), Lot Number: EP241118;
46) 401863RH, UDI-DI: 10197344044399(each), 10197344044399(case), Lot Number: EP250106;
47) 401864RH, UDI-DI: 10197344044405(each), 10197344044405(case), Lot Number: EP241118;
48) 401864RH, UDI-DI: 10197344044405(each), 10197344044405(case), Lot Number: EP250106;
49) 401877RH, UDI-DI: 10197344044436(each), 10197344044436(case), Lot Number: EP241118;
50) 401878RH, UDI-DI: 10197344044443(each), 10197344044443(case), Lot Number: EP241118;
51) 401890RH, UDI-DI: 10197344044450(each), 10197344044450(case), Lot Number: EP241118;
52) 401890RH, UDI-DI: 10197344044450(each), 10197344044450(case), Lot Number: EP250106;
53) 401891RH, UDI-DI: 10197344044467(each), 10197344044467(case), Lot Number: EP241118;
54) 401966RH, UDI-DI: 10197344044498(each), 10197344044498(case), Lot Number: EP250106;
55) 402004RH, UDI-DI: 10197344044566(each), 10197344044566(case), Lot Number: EP241118;
56) 402004RH, UDI-DI: 10197344044566(each), 10197344044566(case), Lot Number: EP250106;
57) 402008RH, UDI-DI: 10197344044573(each), 10197344044573(case), Lot Number: EP241118;
58) 402010RH, UDI-DI: 10197344044597(each), 10197344044597(case), Lot Number: EP241118;
59) 402010RH, UDI-DI: 10197344044597(each), 10197344044597(case), Lot Number: EP250106;
60) 402012RH, UDI-DI: 10197344043835(each), 10197344043835(case), Lot Number: EP241118;
61) 402012RH, UDI-DI: 10197344043835(each), 10197344043835(case), Lot Number: EP250106 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | An Urgent Medical Device Recall notification letter dated 7/14/25 was sent to customers.
REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product immediately.
2. Please complete and return the enclosed response form via email to: recalls@medline.com or fax: 866-767-1290, listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form.
3. Upon receipt of your submitted response form, return labels and RGA information will be provided, if applicable. Your account will receive credit when the returned product is received.
4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request your customers return any affected product to you for collection and return to Medline Industries, LP.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 398 units |
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| Distribution | US Nationwide. |
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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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| 510(K) Database | 510(K)s with Product Code = NLH
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