Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
USCentimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
Recalling Firm: Cook Incorporated
Reason for Recall / Hazard
TranslatedMarker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Product Description & Identification
TranslatedCentimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
Affected Products
TranslatedCentimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
Additional Source Details
| Field | Value |
|---|---|
| City | Bloomington |
| State | IN |
| Event id | 98682 |
| Address 1 | 750 N Daniels Way |
| Code info | UDI-DI 00827002119161 Lots 16905390 16905390X 16888263 NS16888264 16905391 16905391X 16909577 16918137 16924645 16924646 16928311 16928311X 16928312 16928313 16947353 16899656 16899655 16894976 16879299 16890985 16903201 16885859 16890986 16890982 16888268 16904428 16899658 16903202 16903203 16903204 16905389 16888267 16890983 16888269 16890981 16879296 16864346 16879301 16888261 16864344 16864351 16846774 16869144 16879300 16864350 16869143 16869143X NS16861721 16879297 16861735 16864347 16864347X 16882666 16899657 16890984 16899659 16888266 16861729 16857145 16858460 16857141 16861730 16861724 16858463 16852206 16855698 16858458 16858461 16858462 16858462X 16861726 16861727 16861728 16852209 16855686 16855696 16857146 16859718 16861720 16861723 16861725 16857137 16857142 16857139 16857140 16877835 16864345 16882665 16864353 16864348 16865462 16865462X 16879302 16843256 16833320 16843258 16845235 16845236 16839886 16845242 16845244 16845223 16845223X 16845226 16846777 16845230 1684522... [TRUNCATED] |
| Postal code | 47404-9120 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 11,253 |
| Reason for recall | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260402 |
| Initial firm notification | Letter |
| Center classification date | 20260501 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures a...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
Check Other Products In Your Household
Free Safety ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Overview
- Recalling FirmCook Incorporated
- StatusOngoing
- Risk LevelClass I
- DistributionUS distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay
📢 Share Warning
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Cook Incorporated - Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience. Check if your household is affected: https://therecallfile.com/recalls/centimeter-sizing-catheter-rpn-n5-0-35-100-p-10s-pig-csc-20-gpn-g11916/FDA-Z-1934-2026
Join Alertlist
Get instant email updates whenever critical safety recalls like this are published.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Related Recalls
UKField Safety Notices: 31 August to 4 September 2026
Field Safety Notices: 31 August to 4 September 2026
List of Field Safety Notices from 31 August to 4 September 2026....
AustraliaNutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables
Nutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables
Vitaco Health Australia Pty Ltd (Vitaco) is alerting customers that sucralose, an artificial sweetener, was used in 23 batches of Nutra-life and Musashi products rather than thaumatin, a natural sweet...
AustraliaAidacare Aspire Active Air 8 Pressure Care Air Mattress
Aidacare Aspire Active Air 8 Pressure Care Air Mattress
Aidacare Pty Ltd has updated the user manual for the Aspire Active Air 8 Pressure Care Mattress to add setup instructions and warnings about using the device in the presence of oxygen enriched environ...