Reported Oct 5, 2022 · Ongoing

Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145…

Cook Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

9 of 9 products

Products covered by this recall
Model / number	Product as published
`G34131`	Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5
`G18154`	RPC-035145
`G34132`	RPC-035145-5
`G34129`	RPC-038145-0-5
`G17539`	RFSPC-038145-0
`G17540`	RFSPC-035145
`G18155`	RPC-038145-0
`G18153`	RPC-035145-0
`G17542`	RFSPC-035145-0

Lot codes and dates: RPC-035145-0-5 G34131 UDI-DI00827002341319
Lot/Expiration Date
14769270X
03-06-2025
14802181
20-06-2025
14816224
28-06-2025
14818488
29-06-2025
14818489
29-06-2025
14828627
06-07-2025
14828629
06-07-2025
RPC-035145 G18154 UDI-DI00827002181540
Lot/Expiration Date
14770863
06-06-2025
14770864
06-06-2025
14813490
27-06-2025
14816227
28-06-2025
NS14770866
06-06-2025
NS14804982
21-06-2025
RPC-035145-5 G34132 UDI-DI00827002341326
Lot/Expiration Date14770872 06-06-2025 14810022 23-06-2025 14831440 07-07-2025
RPC-038145-0-5 G34129 UDI-DI00827002341296
Lot/Expiration Date14804972 21-06-2025 14809971 23-06-2025
RFSPC-038145-0 G17539 UDI-DI00827002175396
Lot/Expiration Date14809157 23-06-2025 14837048 12-07-2025
RFSPC-035145 G17540 UDI-DI00827002175402
Lot/Expiration Date
14818484
29-06-2025
14818485
29-06-2025
14818490
29-06-2025
14840310
13-07-2025
RPC-038145-0 G18155 UDI-DI00827002181557
Lot/Expiration Date
14819269
29-06-2025
14823406
01-07-2025
14832976
08-07-2025
NS14828649
06-07-2025
RPC-035145-0 G18153 UDI-DI00827002181533
Lot/Expiration Date
14828625
06-07-2025
14828630
06-07-2025
14828635
06-07-2025
14828636
06-07-2025
14828637
06-07-2025
14828640
06-07-2025
14828641
06-07-2025
14841469
14-07-2025
NS14813479
27-06-2025
NS14818486
29-06-2025
RFSPC-035145-0 G17542 UDI-DI00827002175426
Lot/Expiration Date14844152 15-07-2025
Amount recalled: 56 US; 1033 OUS

This recall covers 24 products

The agency filed one notice per product. You are reading one of them; the other 23 are below.

11 more are in the archive.

Where it was sold

Nationwide

Why it was recalled

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Other recalls from Cook Incorporated

15 in total.

All recall categories · Browse the whole archive