Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.
USMedline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.
Recalling Firm: Medline Industries, LP
Motivo del Retiro / Peligro
TranslatedMedline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Descripción del Producto e Identificación
TranslatedMedline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.
Productos Afectados
TranslatedMedline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98226 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | Medline Kit SKU DYNJ0972604A: UDI/DI 10889942403905 (EA) 40889942403906 (CS), Lot Number 25KMD144; Medline Kit SKU DYNJ33822L: UDI/DI 10198459385582 (EA) 40198459385583 (CS), Lot Number 25KMD419; Medline Kit SKU DYNJ45640B: UDI/DI 10193489494983 (EA) 40193489494984 (CS), Lot Number 25KMD793; Medline Kit SKU DYNJ63377D: UDI/DI 10198459514579 (EA) 40198459514570 (CS), Lot Number 25KMI988; Medline Kit SKU DYNJ65011D: UDI/DI 10198459017018 (EA) 40198459017019 (CS), Lot Number 25KMH161; Medline Kit SKU DYNJ69143C: UDI/DI 10198459478505 (EA) 40198459478506 (CS), Lot Number 25LMB211; Medline Kit SKU DYNJ69313: UDI/DI 10193489931822 (EA) 40193489931823 (CS), Lot Number 25KMJ489; Medline Kit SKU DYNJ86007B: UDI/DI 10198459260452 (EA) 40198459260453 (CS), Lot Number 25KDB551. |
| Postal code | 60093-2753 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 1,928 total |
| Reason for recall | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251212 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260128 |
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 Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKE...?
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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Resumen
- Empresa ResponsableMedline Industries, LP
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionUS Nationwide distribution.
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🚨 SAFETY ALERT: Medline Industries, LP - Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B. Check if your household is affected: https://therecallfile.com/es/recalls/medline-medical-procedure-convenience-kits-labeled-as-1-pacer-cath-lab/FDA-Z-1188-2026
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