Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; 3) 82121 Ch12-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82121; 4) 82141 Ch14-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82141; 5) 82084 Ch08 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82084; 6) 82104 Ch10 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82104; 7) 82124 Ch12 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82124; 8) 82144 Ch14-40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82144; 9) 82164 Ch16 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82164; 10) 85124 CH12 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85124; 11) 85144 CH14 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85144; 12) 85164 CH16 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85164.
Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; 3) 82121 Ch12-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82121; 4) 82141 Ch14-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82141; 5) 82084 Ch08 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82084; 6) 82104 Ch10 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82104; 7) 82124 Ch12 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82124; 8) 82144 Ch14-40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82144; 9) 82164 Ch16 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82164; 10) 85124 CH12 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85124; 11) 85144 CH14 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85144; 12) 85164 CH16 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85164.
Recalling Firm: Hollister Ulc
Grund für den Rückruf / Gefahr
TranslatedHollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.
Produktbeschreibung & Identifikation
TranslatedOnli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; 3) 82121 Ch12-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82121; 4) 82141 Ch14-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82141; 5) 82084 Ch08 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82084; 6) 82104 Ch10 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82104; 7) 82124 Ch12 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82124; 8) 82144 Ch14-40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82144; 9) 82164 Ch16 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82164; 10) 85124 CH12 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85124; 11) 85144 CH14 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85144; 12) 85164 CH16 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85164.
Betroffene Produkte
TranslatedOnli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; 3) 82121 Ch12-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82121; 4) 82141 Ch14-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82141; 5) 82084 Ch08 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82084; 6) 82104 Ch10 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82104; 7) 82124 Ch12 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82124; 8) 82144 Ch14-40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82144; 9) 82164 Ch16 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82164; 10) 85124 CH12 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85124; 11) 85144 CH14 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85144; 12) 85164 CH16 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85164.
Additional Source Details
| Field | Value |
|---|---|
| City | Ballina |
| State | N/A |
| Event id | 99497 |
| Address 1 | Foxford Road |
| Address 2 | REHINS |
| Code info | SKU/REF 82081, UDI/DI 00610075072354, Lot Numbers: 5F273, 5F283, 5H293, 5J153, 6C313. SKU/REF 82101, UDI/DI 00610075072361, Lot Numbers: 5F283, 5G013, 5K253, 6A303. SKU/REF 82121, UDI/DI 00610075072385, Lot Numbers: 5H283, 5H293, 5K183, 5K193, 5K213, 6A253, 6A263, 6B053. SKU/REF 82141, UDI/DI 00610075072392, Lot Numbers: 5E063, 5E073, 5E083, 5F193, 5F203, 5F213, 5F223, 6B133. SKU/REF 82084, UDI/DI 00610075072408, Lot Numbers: 5E293, 5G213, 5G223, 6A223, 6A213. SKU/REF 82104, UDI/DI 00610075072415, Lot Numbers: 5E293, 5E303, 5G243, 5G253, 5J063, 5J073, 5L153, 6D203, 6E293. SKU/REF 82124, UDI/DI 00610075072422, Lot Numbers: 5E303, 5F033, 5F063, 5F043, 5F053, 5J223, 5J283, 5J243, 5K143, 6A163, 6A153, 6B173, 6B183, 5F073. SKU/REF 82144, UDI/DI 00610075072439, Lot Numbers: 6A163, 5F113, 5F133, 5I073, 5G083, 5E243, 5E253, 5E233, 5F103, 5I123, 5F143, 5E263, 5E273, 5I113, 5E283, 5F123, 5F153, 5G093, 5G183, 5G173, 5I153, 5I133, 5I143, 5I063, 6A173, 6B243, 5I103, 6B2... [TRUNCATED] |
| Postal code | N/A |
| Report date | 20260902 |
| Product type | Devices |
| Product quantity | 2526120 units |
| Reason for recall | Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260714 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260821 |
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 Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermit...?
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.
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Übersicht
- Rückrufendes UnternehmenHollister Ulc
- StatusOngoing
- RisikostufeClass II
- DistributionUS Nationwide distribution.
📢 Warnung teilen
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Hollister Ulc - Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; 3) 82121 Ch12-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82121; 4) 82141 Ch14-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82141; 5) 82084 Ch08 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82084; 6) 82104 Ch10 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82104; 7) 82124 Ch12 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82124; 8) 82144 Ch14-40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82144; 9) 82164 Ch16 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82164; 10) 85124 CH12 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85124; 11) 85144 CH14 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85144; 12) 85164 CH16 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85164. Check if your household is affected: https://therecallfile.com/de/recalls/onli-17cm-hydrophilic-urethral-intermittent-catheter-labeled-as-1-8208/FDA-Z-2998-2026
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