[pending] HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD
Pending LLM rewrite. Source: FDA_DEVICE Z-0288-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
The recalled product
- Product
- HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
- Manufacturer
- HeartSine Technologies Ltd
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- PAD-PAK-01
- Lot: H017-002-174 and H047-002-100
- UDI: 0506016712046
- PAD-PAK-02
- Lot: H023-002-051
- UDI: 0506016712047
- PAD-PAK-03
- Lot: H017-002-173
- H047-002-101
- UDI: 0506016712123
- PAD-PAK-04
- Lot: H023-002-050
- UDI: 0506016712124
- PAD-PAK-07
- Lot: H017-002-178
- UDI: 0506016712448
- PAD-PAK-03J
- Lot: H017-002-071 and H047-002-035
- UDI: 0506016712475
- PAD-PAK-04J
Distribution
Distributed nationwide across the United States.
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