Defibrillator pad packs recalled over damaged pins disrupting electrical contact
HeartSine Technologies is recalling 1,291,165 Pad-Pak units because defibrillator pads may contain damaged pins that disrupt the mechanical fit and electrical contact.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: damaged pins can disrupt electrical contact on a defibrillator accessory, and no injuries are reported.
Plain-English summary
HeartSine Pad-Pak units, REF PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J and PAD-PAK-04J, are being recalled.
Following customer complaints, the firm states that defibrillator pads may contain damaged pins that disrupt the mechanical fit and electrical contact.
The recall covers 1,291,165 units, including PAD-PAK-01 lots H017-002-174 and H047-002-100 (UDI 0506016712046) and PAD-PAK-02 lot H023-002-051. Distribution was nationwide in the United States and worldwide to Argentina, Australia, Austria, Bahrain, Belgium and Brazil among other countries. The FDA has classified the action as Class II.
The enforcement record describes the pin damage and reports no injuries. Because these pads connect the defibrillator to the patient, holders of affected lots should follow HeartSine's instructions and ensure a serviceable Pad-Pak is available.
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
- Affected units
- 1,291,165
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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