Reported May 27, 2020 · Terminated
Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as…
Medline Industries Inc.
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 Inc · Three Lakes Drive · Northfield, IL · 60093
Is this the product you have?
496 of 496 products
| Model / number | Product as published |
|---|---|
DYNJ906478 | — |
| — | Lot Numbers: 19HDC844, 19JDC085, 19KDB380 ABDOMINAL HYSTERECTOMY |
DYNJ906478A | — |
| — | Lot Number 20BDB181 ACCESSORY HIP PACK-LF |
DYNJ0781865M | — |
| — | Lot Numbers: 18BK2574, 18DK0496, 18EKA073, 18FKA858, 18GKA188, 18IKA759, 18JKD361 ARTHRO/SHOULDER PACK |
DYNJ30056J | — |
| — | Lot Numbers: 17GB8081, 18EBS087 ARTHRO/SHOULDER PACK |
DYNJ30056K | — |
| — | Lot Numbers: 18GBJ657, 18IBN476, 19ABH842, 19DBU977, 19FBP229, 19TBE271 ARTHRO/SHOULDER PACK |
DYNJ30056L | — |
| — | Lot Numbers: 19KBL220, 19LBS330 ARTHRO/SHOULDER PACK |
DYNJ30056M | — |
| — | Lot Number 20ABZ544 BODY PACK |
DYNJ55107A | — |
| — | Lot Number 17JB4285 BODY PACK |
DYNJ55107C | — |
| — | Lot Numbers: 18DB3384, 18EBM509, 18FBF508, 18GBJ600, 18OB2061 BODY PACK |
DYNJ55107D | — |
| — | Lot Numbers: 18IBI923, 19DBW962, 19FBK979, 19IBR719, 19KBW640, 20ABF961 C SECTION CDS |
- Amount recalled
- 92,902 kits
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.
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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