Reported Aug 9, 2023 · Ongoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following
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?
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following
26 of 26 products
| Model / number | Product as published |
|---|---|
DYNJ909031 | (54) KIT STC PLASTIC FREE FLAP |
DYNJ904598B | BREAST |
DYNJ63893 | BREAST DBL PROCED SUPPLEMENT |
DYNDH1306 | BREAST PACK |
DYNDH1389B | BRST BX TRAY |
DYNJ61084A | CMC BREAST BIOPSY TRAY-LF |
DYNJ60669F | DBD-DIEP PACK |
DYNJ907802 | DBD-FREE FLAP |
DYNJ83286 | DBD-FREE FLAP PACK |
DYNJ905004B | DBD-MAJOR BREAST |
SYNJ910024A | DBD-PLASTICS FREE FLAP |
DYNJ82250 | DELNOR SIMPLE PLASTIC PACK |
DYNJ905702C | DIEP, , DYNJ905702D |
DYNJ904762D | DIEP FLAP CDS |
DYNJ60669C | DIEP PACK, , DYNJ60669D |
DYNJ58272C | FH BREAST FLAP PACK, , DYNJ58272D |
DYNJ900845B | FLAP KIT |
DYNJ48191G | FLAP PACK, , DYNJ48191I, DYNJ48191J, DYNJ60224B |
DYNJ0378388P | FLAP RECONSTRUCTION PACK-LF |
DYNJ906823A | FREE FLAP, , DYNJ906823B |
- Amount recalled
- 11,436 kits
This recall covers 50 products
The agency filed one notice per product. You are reading one of them; the other 49 are below.
37 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
This product could cause temporary or reversible health problems — stop using it.
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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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