Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
USIntubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Recalling Firm: Medline Industries, LP
Motif du rappel / Danger
TranslatedA smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Description du produit & Identification
TranslatedIntubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Produits concernés
TranslatedIntubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98285 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318 |
| Postal code | 60093-2753 |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | 130 |
| Reason for recall | A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251224 |
| Initial firm notification | Letter |
| Center classification date | 20260206 |
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 Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B?
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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Aperçu
- Entreprise responsableMedline Industries, LP
- StatusOngoing
- Niveau de risqueClass II
- DistributionDistribution US nationwide and Canada.
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🚨 SAFETY ALERT: Medline Industries, LP - Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B Check if your household is affected: https://therecallfile.com/fr/recalls/intubation-tray-adult-containing-suction-catheter-kits-sku-dynjaa245b/FDA-Z-1313-2026
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