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Pad-Pak recallZ-2143-2023 · HeartSine Technologies Ltd · initiated Apr 26, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from HeartSine Technologies Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.

FDA root cause category: Process control

What the company is doing

On 5/16/2023, Stryker, (parent company to HeartSine Technologies) issued an "URGENT MEDICAL DEVICE CORRECTION" notification via UPSP Certified Mail. The firm made the decision to expand the recall and On 8/20/2023 notified additional consignees. The notification asked consignees to take the following actions: 1. Inspect your Pad-Pak inventory to identify if you have any of the affected lot numbers listed on page 1. a. If affected Pad-Paks are found, please request replacement by emailing [email protected]. 2. Complete the attached acknowledgment form and return it by email to [email protected] confirming your receipt and understanding of this information. a. Upon receipt of the acknowledgment form, Stryker will arrange for the shipment of replacement Pad-Pak(s) at no charge to you. 3. In the interim, please continue monitoring the AED to ensure the status indicator is flashing green every 5 to 10 seconds. Please contact your Authorized Distributor or HeartSine Technologies immediately if you identify either of the following situations: a. If the status indicator is flashing red or you hear continuous beeping. b. If there is no status indicator operative. 4. Once you receive the replacement Pad-Paks, please destroy the affected Pad-Paks per local disposal guidelines. 5. Maintain awareness of this communication internally until the required action has been completed within your facility. 6. Inform Stryker if any of the subject Pad-Paks have been distributed to other organizations. a. If further distributed, please send an email to [email protected] notifying Stryker of further distribution. b. Please use attached Customer Letter to notify your customers immediately. Stryker will work with you to ensure recipients are notified appropriately. 7. If you have any questions or concerns, please contact HeartSine Customer Support at +44 28 9093 9400, 9:00 A.M. to 5:00 P.M. (GMT), Monday Friday or by email at [email protected].

Recall details

Recall number
Z-2143-2023
Status
Open, Classified
Initiated by the company
Apr 26, 2023
Posted by the FDA
Jul 13, 2023
Recalling firm
HeartSine Technologies Ltd
Quantity
30,022 units
Product code
MKJ
FDA submissions
P160008
Distribution
Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA & WI and OUS (countries of): Australia, Canada, Denmark, France, Iceland, Ireland, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Peru, Poland, Singapore, South Africa, Spain, Thailand, & United Kingdom.

Product description

HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Model #/UDI-DI #: 360-BAS-UK-10/05060167122606, 350-BAS-UK-10/05060167121418, 350-BAS-AS-10/05060167121371, 350-BAS-CF-10/05060167124747, 350-BAS-CN-10/05060167121593, 350-BAS-JA-08/05060167124525, 350-BAS-KO-10/05060167121517, 350-BAS-MS-10/05060167120800, 350-BAS-USROW-10/05060167121630, 360-BAS-AS-10/05060167122514, 360-BAS-CN-10/05060167125751, 360-BAS-KO-10/05060167122712, 360-BAS-SJ-10/05060167128028, 450-BAS-JA-08/05060167127663, 500-BAS-AS-10/05060167125812, 500-BAS-CF-10/05060167125836, 500-BAS-CN-10/05060167125843, 500-BAS-KO-10/05060167126444, 500-BAS-TH-10/05060167125997, 500-BAS-UK-10/05060167122453, PAD-PAK-01/05060167120466,PAD-PAK-03/05060167121234,PAD-PAK-03j/05060167124754 Models/Lot # 360-BAS-UK-10/ A3659, A3655, A3664, A3654, A3803, A3829, A3840, A3842, A3848, A3840, A3843, A3842, A3844, A3842, J0754, J0754, J0755, J0752, J0798; 350-BAS-UK-10/ A3664, A3799, A3803, A3829,A3840,A3846, J0753, J0753, J0754, J0756; 350-BAS-AS-10/ A3656; 350-BAS-CF-10/ A3635, A3805, J0801; 350-BAS-CN-10/ A3633, A3636, A3805, A3833, J0801; 350-BAS-JA-08/ A3779 A3783, A3780, A3783, J0758, J0758; 350-BAS-KO-10/ J0753; 350-BAS-MS-10/ J0753; 350-BAS-USROW-10/ A3644; 360-BAS-AS-10/ A3656; 360-BAS-CN-10/ A3635; 360-BAS-KO-10/A3660 A3646, A3665, J0753, J0754; 360-BAS-SJ-10/ A3660; 450-BAS-JA-08/ A3779, A3783, A3788, A3821; 500-BAS-AS-10/ A3656; 500-BAS-CF-10/ A3635; 500-BAS-CN-10/ A3632, A3635, A3634, A3681; 500-BAS-KO-10/ A3660; 500-BAS-TH-10/ J0754, J0755, J0754; 500-BAS-UK-10/ A3654, A3654, A3664, A3664, A3765, A3787, A3801, A3840, J0753, J0755, J0754, J0756, J0748, J0798; PAD-PAK-01/ A3632 A3633 A3634 A3635 A3636 A3637 A3642 A3656 A3657 A3657 A3657 A3662 A3669 A3681 A3678 A3682 A3766, A3777 A3778 A3781 A3782 A3805 A3807 A3833 A3833 A3834 A3834 A3832 A3840 J0759 J0761 J0760; PAD-PAK-03/ A3638 A3639 A3640 A3658 A3644 A3644 A3655 A3666 A3653 A3652 A3641 A3643 A3660 A3664 A3665 A3672 A3663 A3668 A3667 A3661 A3659 A3764 A3765 A3770 A3772 A3773 A3774 A3775 A3776 A3779 A3784 A3785 A3786 A3787 A3787 A3785 A3799 A3799 A3800 A3801 A3802 A3802 A3803 A3804 A3829 A3829 A3840 A3845 A3846 A3847 A3849 A3849 A3845 J0749 J0749 J0748 J0750 J0751 J0752 J0753 J0753 J0754 J0756 J0786 J0786 J0790 J0791 J0787 J0788 J0788 J0789 J0792 J0792 J0795 J0794 J0793 J0792 J0796 J0797 J0798 J0799; PAD-PAK-03j/ A3788 and A3821

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

15 devices cleared under P160008 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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