FDA Medical Device Recalls (openFDA)
Heartsine Technologies, Limited: Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.
- Recall number
- Z-2115-2014
- Recalling firm
- Heartsine Technologies, Limited
- Product
- Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.
- Status
- Terminated
- Initiated
- 2014-06-12
- Posted
- 2014-07-24
- Terminated
- 2015-04-16
- Reason
- A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
- Root cause
- Packaging process control
- Action
- HeartSine notified distributors in the United States by e-mail on June 12, 2014 and by follow-up letter on June 13, 2014. Distributors were given a letter to use in communications with customers on June 17, 2014. Customers were instructed to return affected product to there distributors. Distributors were asked to return the affected product to HeartSine. In order to effect an immediate return, replacement Pad-Paks and Pedi-Paks have already been delivered to all respective distributors. A seconde letter, dated June 30th, was sent to end users to clarify where on the label to find lot specific information. For question contact Quality Manager at +44 (0)28 90 93 94 19.
- Quantity
- 3245
- Distribution
- Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
- Lot, serial or model codes
- Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.
- 510(k) numbers
- ["K052465","K123881"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3004123209
- Firm city
- Belfast
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28