Recall record at a glance
| Official record | Z-2143-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | HeartSine Technologies Ltd |
| Report date | Jul 19, 2023 |
| Recall initiation date | Apr 26, 2023 |
| Quantity | 30,022 units |
| Location | Belfast, N/A, United Kingdom |
Official 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
Why the product 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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