Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated Ext
FDA device recall Z-2115-2014 · posted 2014-07-24 · Terminated
Recall details
- Recalling firm
- Heartsine Technologies, Limited
- Reason for recall
- A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 3245
- Distribution
- Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
- Date initiated
- 2014-06-12
- Date posted
- 2014-07-24
- Date terminated
- 2015-04-16
- Location
- Belfast, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSINE SAMARITAN PAD 350P (K123881) | Heartsine Technologies, Inc. | 2013-07-11 |
| REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 (K052465) | Heartsine Technologies, Inc. | 2006-12-12 |