Recall Z-2143-2023 · MKJ Automated External Defibrillators (Non-Wearable)

HeartSine Technologies Ltd

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

Date	Jul 13, 2023 (initiated Apr 26, 2023)
Status	Open, Classified
Reason	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.
Root cause	Process control
Action	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 RSRecal
Quantity	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 (countries of): Australia, Canada, Denmark, France, Iceland, Ireland, Israel, Italy, Japan, Korea,
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.