HeartSine Technologies Ltd: 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

Hazard

Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.

Details from the source

Reason for recall: Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. Distribution: US Nationwide distribution. Worldwide distribution to Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, Quantity: 1,291,165 units Lot/code info: 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, Lot: H023-002-009, UDI: 0506016712476

UPC codes

0506016712046, 0506016712047, 0506016712123, 0506016712124, 0506016712448, 0506016712475, 0506016712476

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.