Cap Recall: Surepulse VS Large SP-162-A1
FDA recall of SUREPULSE MEDICAL LTD for the Surepulse VS Cap Large SP-162-A1 component of the VS Newborn Heart Rate Monitor due to retroactively reported labeling that provides an incorrect sizing guide for the Cap. The recall involves DI Number: 05060550650044 and Lot numbers 13816/00001 through 13840/00001, with worldwide distribution including US states CT and TX and the United Kingdom, the Netherlands, and the United Arab Emirates. The recall severity is low.
| Brand | SUREPULSE MEDICAL LTD |
|---|---|
| Product | Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor |
| Reason | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. |
| Severity | low |
| Units affected | N/A |
| Distribution | Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Check if you own the affected Cap Large SP-162-A1 by reviewing the listing for the DI number and the relevant lot numbers (13816/00001 to 13840/00001).
- Contact your healthcare provider or medical device supplier for guidance on next steps or replacement.
- Monitor FDA updates and Surepulse Medical Ltd notices for further instructions.
How to identify the recalled item
| Lot / date codes | DI Number: 05060550650044/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001 |
|---|---|
| Lot / date codes | DI Number: 05060550650037/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.