Reported Jul 25, 2018 · Terminated
Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin…
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications |
| 2 | up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner |
| 3 | up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery. |
- Lot codes and dates
- Product Code SP4692448A (Lot Numbers 820354, 821943, 826374, 833181). Product Code SP4692448B (Lot Number 849841, 855450).
- Amount recalled
- 8,928 kits total
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
- Nationwide
- CA
Why it was recalled
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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