HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public A

FDA device recall Z-2143-2023 · posted 2023-07-13 · Open, Classified

Recall details

Recalling firm

HeartSine Technologies Ltd

Reason for recall

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.

Action taken

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 RSRecall@stryker.com. 2. Complete the attached acknowledgment form and return it by email to RSRecall@stryker.com 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 RSRecall@stryker.com 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 RSRecall@stryker.com.

Root cause

Process control

Status

Open, Classified

Product code

MKJ

Quantity affected

30,022 units

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

Date initiated

2023-04-26

Date posted

2023-07-13

Location

Belfast, United Kingdom