Reported Jul 10, 2024 · Ongoing
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder…
MEDLINE INDUSTRIES, LP - Northfield
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: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Non-sterile convenience kitsMedline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile
- Lot codes and dates
- Pack #CDS981759C - Lot numbers 24ADA460, exp. 7/31/2025; 23KDB724, exp. 7/31/2025; 23JDA205, exp. 10/31/2025; 23IDA683, exp. 11/30/2025; and 23EDA124, exp. 5/31/2025; UDI-DI each-10888277524002 and UDI-DI case-5/31/2025.
- Amount recalled
- 7,673 total non-sterile kits
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
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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